FACULTY OF RADIATION ONCOLOGY

THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS®

POSITION PAPER TECHNIQUES AND TECHNOLOGIES IN RADIATION ONCOLOGY 2015 HORIZON SCANAUSTRALIA AND NEW ZEALAND

Name of document and version:Position Paper Techniques and Technologies in Radiation Oncology 2015 Horizon Scan Australia and New Zealand

Approved by: Faculty of Radiation Oncology Council

Date of approval:29 April 2016

ABN 37 000 029 863Copyright for this publication rests with The Royal Australian and New Zealand College of Radiologists®

The Royal Australian and New Zealand College of RadiologistsLevel 9, 51 Druitt StreetSydney NSW 2000Australia

Email: ranzcr@ranzcr.edu.auWebsite: www.ranzcr.edu.auTelephone: +61 2 9268 9777Facsimile: +61 2 9268 9799

Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and his/her doctor.

CONTENTS

Objectives ............................................................................................................... 3About Radiation Oncology ................................................................................... 3FRO Horizon Scanning – Why? ............................................................................ 3FRO Definition of Radiation Therapy Techniques ............................................. 4FRO Definition of Radiation Therapy Technologies ........................................... 4Why Differentiate between Techniques and Technologies? .............................. 4Faculty of Radiation Oncology Position .............................................................. 4Radiation Oncology Techniques .......................................................................... 5

Image Guided Radiation Therapy (IGRT) .......................................................... 5Intensity Modulated Radiation Therapy (IMRT) .................................................. 5Stereotactic Radiation Therapy (SRT), Radiosurgery (SRS), Stereotactic Body Radiation Therapy (SBRT), and Stereotactic Ablative Body Radiation Therapy (SABR) ............................... 6Advanced Imaging for Treatment Planning ....................................................... 6Motion Management Techniques for Radiation Therapy Treatment ................... 7Adaptive Radiation Therapy ............................................................................... 7Brachytherapy .................................................................................................... 7Particle Therapy ................................................................................................. 8

Appendix I: Horizon Scan Table ........................................................................... 9Appendix II: Radiation Oncology Delivery Technologies ................................ 14Appendix III: Related Innovations ...................................................................... 21Appendix IV: Glossary ......................................................................................... 24Acknowledgement ............................................................................................... 26References ........................................................................................................... 26

THE FACULTY OF RADIATION ONCOLOGY, RANZCR, is the peak bi-national body advancing patient care and the specialty of Radiation Oncology through setting of quality standards, producing excellent Radiation Oncology specialists, and driving research, innovation and collaboration in the treatment of cancer.

VISIONTo have an innovative, world class Radiation Oncology Specialty for Australia and New Zealand focused on patient needs and quality.

OUR VALUESIn undertaking our activities and in managing the way we interact with our Fellows, trainees, members, staff, stakeholders, the community and all others with whom we liaise, the Faculty of Radiation Oncology, RANZCR, will demonstrate the following values:

• Quality of Care - performing to and upholding high standards

• Integrity, honesty and propriety - upholding professional and ethical values

• Patient orientation - understanding and reflecting the views of Fellows and members and workingwith them to achieve the best outcomes

• Fiscal responsibility and efficiency - using the resources of the College prudently.

OUR PROMISE TO THE PATIENTSWe will advocate for the best possible care for individual patients in multidisciplinary meetings and for all patients with government.

OUR PROMISE TO TRAINEESWe ensure the highest standard of training in radiation oncology by combining a world-class curriculum with passionate and supportive supervisors. The voice of trainees is valued in Radiation Oncology.

OUR PROMISE TO OUR FELLOWSWe are a member based organisation that utilises its resources effectively and strategically to fulfil our vision, purpose and core objectives. We strive for best practice and facilitate life-long learning of our members.

OUR PROMISE TO OUR PARTNERS & STAKEHOLDERSWe are a transparent and collaborative organisation that strives to promote partnerships and participation of all relevant stakeholders to ensure that patients across Australia and New Zealand receive a high-quality, timely and appropriate level of care.

CODE OF ETHICSThe Code defines the values and principles that underpin the best practice of clinical radiology and radiation oncology and makes explicit the standards of ethical conduct the College expects of its members.

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OBJECTIVESThe aim of the paper is to inform cancer professionals, health professionals, health administrators, consumers and interested individuals about the techniques and technologies used for safe delivery of high quality radiation therapy.

ABOUT RADIATION ONCOLOGYRadiation oncology is a specialty in which highly trained oncologists use their knowledge of radiation cell biology, and technology to treat cancer with radiation. Radiation therapy can be used to treat almost all cancers, anywhere in the body. Radiation oncology has a major positive impact on local cancer control and is a highly effective therapy for control of cancer symptoms such as pain or bleeding. The safe and accurate delivery of this treatment requires the skills of a multidisciplinary team of radiation oncologists, radiation oncology medical physicists and radiation therapists as well as cancer nurses, engineers and allied health staff. The treatment (radiation) is delivered using various specifically chosen techniques to deliver a prescribed radiation dose to the target (such as a tumour) while ensuring that the radiation dose to the surrounding normal tissues is as low as possible.[1]

The overall optimal radiation therapy utilisation rate for all cancer patients, based upon the best available evidence is 48.3%[2]. This means that one in two people diagnosed with cancer would benefit from radiation therapy at some point in their cancer journey. Those patients who miss out on clinically appropriate radiation therapy treatment can be adversely affected. The consequences can include compromised health outcomes, inadequate symptom control, reduced quality of life, increased suffering, and premature death.

Utilisation in Australia between 2001 and 2009 has remained at 38%.[3][4] This is despite a significant investment in radiation therapy infrastructure, which has appeared merely to have kept pace with increases in the number of patients for whom there is an indication for radiation therapy.[5] Utilisation in New Zealand is currently at a national intervention rate of 37.4% (with a range by District Health Board of 27-45%).

FRO HORIZON SCANNING – WHY?There is confusion regarding the difference between advances in treatment techniques, in the technologies used to deliver those techniques, and in the implementation priorities for these techniques and technologies. This information shortfall, along with technology assessment mechanisms that are unsuitable for radiation therapy, have been contributing factors towards slow uptake of new radiation therapy techniques and delivery technologies in Australia and New Zealand compared with other developed and developing countries.

The Faculty of Radiation Oncology is seeking to improve this understanding, via a number of ongoing initiatives, foremost of which is the radiation oncology horizon scanning project that was developed in 2011 and which will be updated with new information and evidence on a biennial basis. This Horizon Scan is to be discussed with key stakeholders that include policymakers, advocacy groups, consumers and industry. This Position Paper is intended to accompany the Horizon Scan (included in Appendix II) that was discussed at the Horizon Scan Industry Roundtable and the Radiation Therapy Innovations Summit in late 2015.

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FRO DEFINITION OF RADIATION THERAPY TECHNIQUES The term technique is used to describe a concept in radiation therapy planning or treatment.

FRO DEFINITION OF RADIATION THERAPY TECHNOLOGIESThe term technology is used to describe a method utilised to deliver a radiation therapy technique.

WHY DIFFERENTIATE BETWEEN TECHNIQUES AND TECHNOLOGIES?As with many other branches of medicine, in radiation oncology there are various vendors and suppliers that produce and distribute treatment equipment. This equipment often has different configurations; however the techniques delivered may be the same or similar. An example of this is Intensity Modulated Radiation Therapy (IMRT). This treatment technique can be delivered by using a number of different technologies; via static fields with a standard configuration linear accelerator, via rotational IMRT delivered with a standard configuration linear accelerator and via helical IMRT that is delivered with a linear accelerator that is mounted in the style of a CT scanner. All of these technologies deliver IMRT, although the technology involved is produced by various manufacturers and can be differently configured. Every attempt has been made in this horizon scan document to use generic terms, rather than proprietary names to describe techniques and technologies.

FACULTY OF RADIATION ONCOLOGY POSITIONIt is the Faculty position that timely patient access to appropriate radiation therapy treatment techniques is of paramount importance. Service planning and reimbursement should be centred on essential radiation therapy techniques. In 2015, the Faculty views the following techniques as being essential (i.e. clinically indicated) for some Australian and New Zealand patients:

• Image Guided Radiation Therapy (IGRT)

• Intensity Modulated Radiation Therapy (IMRT)

• Stereotactic Radiation Treatments (including SRS, SRT and SBRT/SABR)

• Advanced Imaging for Treatment Planning (4DCT, PET-CT, MRI)

• Brachytherapy

• Particle Therapy

These radiation therapy techniques are delivered using a variety of technologies. It is the Faculty position that some techniques must be available in every radiation therapy department i.e. Linear accelerator with IGRT capability, while other techniques may only be justified at one facility in Australia and/or New Zealand i.e. particle therapy. In 2015, the Faculty has reviewed, updated and made public, via its Horizon Scan, its view on implementation prioritiesand projected uptake for radiation therapy treatment techniques and technologies.

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RADIATION ONCOLOGY TECHNIQUES

Image Guided Radiation Therapy (IGRT)Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional imaging that is captured as close as possible to the time of treatment. Positioning correction based on these images is done before and sometimes during treatment delivery.[6] Increasing complexity in planned treatments and individual situations in which setup reproducibility is in question are indications for IGRT.[7] IGRT is an essential component of intensity modulated radiation therapy. Indications for IGRT are included in the Faculty of Radiation OncologyPosition Paper on Image Guided Radiation Therapy (IGRT) 2015.

Delivery Technologies: Daily Online Correction using 2D (MV or KV) or 3D (KV, CBCT or CT on rails), pre-treatment ultrasound imaging, MRI guided IGRT in development.

Priority and Projected Uptake: Some form of IGRT should be available in every radiation oncology facility.

Image guided radiation therapy is currently in use in Australia and New Zealand and it is the Faculty position that image guided radiation therapy is essential for some patients with evidence.

Intensity Modulated Radiation Therapy (IMRT)Intensity modulated radiation therapy (IMRT) is a way of delivering external beam radiation therapy using high energy megavoltage X-rays that allows the radiation dose to conform more closely to the shape of the tumour by changing the intensity of the radiation beam. This technique involves very sharp drop off in effective dose adjacent to both targets and organs at risk, increasing the consequences of any geometric uncertainty (i.e. missing the target),[8][9] making daily image guidance an essential component of quality IMRT. It is the tumour location, size, adjacent organs and dosimetry that define the appropriate role for IMRT, supporting an approach where the clinical circumstances in addition to specific diagnoses are the most important determinants for using IMRT.[10] Failure to deliver radiation therapy accurately has potentially catastrophic consequences for both cancer-control outcomes and normal organ toxicity.[11]

Delivery Technologies: linac based fixed beam IMRT, linac based rotational IMRT[12], helical non C-arm based IMRT and hybrid arc IMRT.

Priority and Projected Uptake: Some form of IMRT should be available in every radiation oncology facility. It is anticipated that the majority of IMRT would be delivered via conventional linac, with several departments per state offering other methods of IMRT delivery.

Intensity modulated radiation therapy is currently in use in Australia and New Zealand and it is the Faculty position, with evidence, that intensity modulated radiation therapy is essential for some patients.

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Stereotactic Radiation Therapy (SRT), Radiosurgery (SRS), Stereotactic Body Radiation Therapy (SBRT), and Stereotactic Ablative Body Radiation Therapy (SABR)Stereotactic radiosurgery allows non-invasive ablative treatment of benign and malignant tumours. It is used for tumours and other lesions (including arteriovenous malformations) that would be inaccessible or inappropriate for open surgery. Although stereotactic radiosurgery is often completed in a one-day session, multiple treatments are sometimes used. The procedure is usually referred to as fractionated stereotactic radiation therapy, when more than two treatments are given and stereotactic body radiation therapy and stereotactic ablative radiation therapy, when treatment is given to areas other than the head. SRS, SRT, SBRT and SABR are alternatives to invasive surgery, including for tumours and abnormalities that are: hard to reach, located close to vital organs.[13]

Delivery Technologies: linac based SRS, cobalt based SRS and robotic SRS.

Priority and Projected Uptake: Some form of Stereotactic Radiation Treatment should be available in several departments per state.

Stereotactic radiation treatment is currently available in Australia and New Zealand and it is the Faculty position, with evidence, that stereotactic radiation treatment is essential for some patients.

Advanced Imaging for Treatment Planning Advanced imaging for treatment planning utilises diagnostic and functional imaging modalities in addition to the CT scan that is used for radiation therapy planning and dosimetry. These advanced planning technologies are 4DCT, which provides organ and tumour motion information, PET, SPECT and hypoxia imaging scans which provides functional information, as well as MRI and ultrasound which show superior soft tissue definition compared with CT scans. These images are fused with the planning CT data set and can be used to provide additional anatomical detail as well as functional and tumour motion information.

Delivery Technologies: 4DCT, PET, SPECT and MRI, with emerging and developing use of many other structural and functional imaging modalities.[14]

Priority and Projected Uptake: Advanced Imaging for Treatment Planning should be available to every radiation therapy facility.

Advanced imaging for treatment planning is currently available in Australia and New Zealand and it is the Faculty position, with evidence, that advanced imaging for treatment planning is essential for some patients.

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Motion Management Techniques for Radiation Therapy TreatmentMotion management techniques in radiation oncology use imaging of anatomy or other surrogates to track and account for the movement of the tumour during treatment. Gated radiation therapy is currently available to manage intra-fraction (during treatment) motion in radiation therapy. In gated radiation therapy treatment, the delivery of radiation is based on the anatomic location of the tumour throughout the breathing cycle (with this information collected via 4DCT or other method). Using gating software, a specific window in the breathing cycle is defined when it is optimal to turn on the radiation beam.[15] Tumour tracking software and hardware is currently in development for both static field and volumetric arc treatments in which imaging follows the movement of the tumour during treatment and the MLC leaves move dynamically to follow this movement.

Several forms of motion management are currently available in Australia and New Zealand, however it is the Faculty position that motion management is currently supported by insufficient evidence to form a view.

Adaptive Radiation TherapyAdaptive radiation therapy systematically manages changes in the cancer size and shape that occur during the radiation therapy course due to treatment response. This can be especially important in cancers that can change in size rapidly over the course of treatment and are located in close proximity to critical dose-limiting structures. Adaptive radiation therapy represents a variation of standard radiation therapy, where a “pre-designed adaptive strategy” replaces the typical single “pre-designed plan”. That is, multiple plans are used as the cancer responds during the course of treatment. This is an area of significant ongoing research, as investigators seek to define the patient groups for whom a pre-designed adaptive strategy would offer the most benefit.[16][17]

Adaptive radiation therapy is currently available in Australia and New Zealand, however it is the Faculty position that adaptive radiation therapy is currently supported by insufficient evidence to form a view.

BrachytherapyConventional brachytherapy uses a radioactive source and automatic afterloader to deliver radiation therapy, whereas electronic brachytherapy utilises a miniature low energy X-ray tube. The source or miniature low energy X-ray tube is inserted into a pre-positioned applicator within body/tumour cavities or on the skin surface to deliver high doses to target tissues with the aim of maintaining low doses to non-target tissues.

Delivery Technologies: conventional high dose rate (HDR) and low dose rate (LDR) radioactive source based brachytherapy, development of electronic brachytherapy and intra-operative brachytherapy.

Priority and Projected Uptake: Brachytherapy should be available in several radiation therapy departments per state.

Brachytherapy treatment is currently available in Australia and New Zealand and it is the Faculty position, with evidence, that brachytherapy is essential for some patients.

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Particle TherapyParticle beam therapy is a form of external beam radiation treatment that uses heavier charged (typically protons, with developing utilisation of pions, or helium, silicon neon, argon or carbon ions[18]) or neutral particles (neutrons) rather than electrons or X-rays. The physical characteristics of the particle therapy beam allow the radiation oncologist to more effectively treat certain types of cancer[19] and other diseases by reducing the radiation dose to nearby healthy tissue. In addition, particle therapy is more effective than photon and electron therapy in causing irreparable cell (both tumour & normal) damage. Particle therapy is used in unique clinical situations.[20]

Delivery Technologies: conformal proton therapy, intensity modulated proton therapy (IMPT), and heavy ion therapy.

Priority and Projected Uptake: Australian patients must have access to particle therapy.

Particle beam therapy is not currently available in Australia or New Zealand, however it is the Faculty position that particle beam therapy is essential for some patients with evidence.

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APPENDIX I: HORIZON SCAN TABLERadiation therapy is a proven, safe, effective and economical cancer treatment, however the radiation oncology sector has not been systematic or strategic in implementing new and evolving technologies in Australia and New Zealand. There is confusion and limited understanding regarding implementation priorities and the difference between advances in treatment techniques and in the technologies used to deliver those techniques.

The purpose of the Horizon Scan is to assist in building expert consensus and to inform policy makers and consumers about the relevance of emerging and evolving techniques and technologies to patient outcomes.

The focus of the Horizon Scan is on clinical relevance. Cost implications of different technologies are outside the scope of this Horizon Scan.

The information contained in this Horizon Scan was initially divided into three tables, showing radiation therapy techniques, technologies and related innovations. As the tables have been revised on an annual basis, the increasing volume of information has required an update to the format. From 2015 onwards, the horizon scan format consists of one table, showing radiation therapy techniques, included in this position paper as Appendix I. Descriptions of the associated radiation oncology technologies are included in Appendix II of this position paper and related innovations are included as Appendix III.

Priority and Projected UptakeThe ‘Priority and Projected Uptake’ described in the ‘Radiation Oncology Techniques’ section of this paper describes the Faculty of Radiation Oncology position relating to the projected uptake of the described technology that may be appropriate for Australia and New Zealand. The projected uptakes noted may change over time as further research is undertaken.

Technique CategoriesThe horizon scan table shows a ‘traffic light’ system to describe the priority category that the Faculty of Radiation Oncology has assigned to the various treatment techniques. The four categories are as follows:

Essential for some patients with evidence

Available alternative

Evidence gathering underway

Not yet commercially available for treatment

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TECHNIQUE TECHNOLOGY USED TO DELIVER THIS TECHNIQUE EXPLANATION SUPPORTIVE STATEMENTS FIRST CLINICAL USE

WORLDWIDE CURRENT UPTAKE IN AUS/NZ TECHNIQUE CATEGORY

Image Guided radiation therapy (IGRT)

Daily online correction using 2D (MV or KV) or 3D (CBCT or CT on rails) imaging. Ultrasound guidance. MRI guided IGRT and 4D-CBCT in development

Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional imaging that is captured as close as possible to the time of treatment. Positioning correction based on these images is done prior to treatment delivery. Increasing complexity in planned treatments and individual situations in which set up reproducibility is in question are indications for IGRT. Gold Standard IGRT is the ability to confirm that the target is within the treatment portal during the entire ‘beam-on’.

FRO Position Statement: “IGRT represents and has represented standard of care radiation oncology practice for many years. Technologies that encourage image guidance are to be supported as a self-evident quality imperative”.

Electronic portal imaging (first generation of image guidance) first commercialised in the early 1990s

99.5% of linear accelerators in Australia and 100% in New Zealand are equipped with electronic portal imaging (2D) and 76.4% of linear accelerators in Australia and 83.9% in New Zealand are equipped with kV Imaging (2D and 3D).

Intensity Modulated radiation therapy (IMRT)

Linac based IMRT, Linac based Rotational IMRT, Helical IMRT, HybridArc IMRT

Intensity Modulated Radiation Therapy (IMRT) is a form of external beam radiation therapy that allows the radiation dose to conform more closely to the shape of the tumour by changing the intensity of the radiation beam. This technique involves very sharp dose gradients adjacent to both targets and organs at risk increasing the consequences of any geometric uncertainty, making daily IGRT is an essential component of quality IMRT.

ASTRO (American Society for Radiation Oncology) believes that tumour location, size, adjacent organs and dosimetry define the appropriate role for IMRT, and support an approach where the clinical circumstances in addition to specific diagnoses are the most important determinants for using IMRT.

1995 99.5% of linear accelerators in Australia and 96.8% in New Zealand are capable of delivering fixed beam IMRT. 72% of linear accelerators in Australia and 74.2% in New Zealand are capable of delivering rotational IMRT. There are 5 non c-arm based linear accelerators delivering helical IMRT in Australia and none in New Zealand.

Stereotactic Radiosurgery (SRS), Stereotactic Radiation Therapy (SRT), and Stereotactic Body Radiation Therapy (SBRT), Stereotactic Ablative Body

Linac based stereotactic radiation treatment, Robotic stereotactic radiation treatment, Cobalt based stereotactic radiation treatment, Helical IMRT based stereotactic radiation treatment

Stereotactic radiosurgery (SRS) allows non-invasive ablative treatment of benign and malignant tumours. It is used for tumours and other lesions that would be inaccessible or inappropriate for open surgery. Although SRS is often completed in a one-day session, multiple treatments are sometimes used. The procedure is usually referred to as fractionated stereotactic radiation therapy (SRT) when more than one treatment is given. SRS, SRT, Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Ablative Body Radiation Therapy (SABR)are alternatives to invasive surgery, especially for patients who are unable to undergo surgery, and for tumors and abnormalities that are: hard to reach, located close to vital organs and/or subject to movement within the body.

Stereotactic radiosurgery (SRS) and stereotactic radiation therapy (SRT) has a well-established role for the treatment of benign and malignant intracranial disease and the efficacy of SRS for the treatment of brain metastases has been demonstrated in several randomised trials. Stereotactic body radiation therapy is increasing in use for sites such as the spine and lung (stage 1 non-small cell lung cancer).

Late 1960s In Australia, 17 facilities deliver SRS, 20 deliver SBRT and 7 deliver both. In New Zealand, 2 facilities deliver both SRS and SBRT.

Radiotherapy (SABR) Advanced Imaging for Treatment Planning

4DCT, PET-CT, MRI, UIltrasound, SPECT-CT, PET Hypoxia Imaging and PET-MRI with MRI fibertracking in development

Computed tomography (CT) scans acquired in the radiation therapy treatment position before the start of radiation therapy remain the basic imaging modality for contouring tumour target volumes and healthy tissues as well as for dose calculation in radiation therapy planning. Standard CT has limitations however, as it only provides anatomical information at one point in time and does not provide functional information. The ability to fuse additional images with the planning CT allows the addition of additional information to the planning process that is not available with conventional CT Scans. PET scans show functional information, 4DCT shows the motion of tumours and/or organs at risk, MRI provides superior soft tissue imaging and MRI fiber tracking show additional anatomical detail that cannot be visualised on conventional CT or standard MRI.

Advanced imaging for use in radiation therapy treatment planning is essential for some patients. Although a planning CT scan is still required at this time for treatment calculations, there are some treatment sites in which other (advanced) imaging techniques provide superior anatomic or functional information. This information can show the location and extent of the tumour with increased clarity, the metabolic activity of the tumour as well as the motion of the tumour and/or adjacent healthy organs.

MRI from early 1980s, PET-CT from late 1990s, 4DCT from 2003

Yes

Motion Management Techniques for Radiation Therapy Treatment

Gated radiation therapy, Motion managed radiation therapy

Motion management techniques for radiation therapy treatment attempt to account for tumour motion during treatment delivery. In gated radiation therapy, the delivery of radiation is based on the anatomic location of the tumour throughout the breathing cycle (with this information collected via 4DCT or other method). Delivery of gated radiotherapy can be done via several means. Using gating software, a specific window in the breathing cycle is defined when it is optimal to turn on the radiation beam. In motion adaptive radiation therapy, the multileaf collimators are moved dynamically to track the movement of a moving tumour (e.g. lung). In addition to motion adaptive treatment of fixed beam radiation therapy, studies are also underway of motion adaptive treatment in volumetric arc treatment. Another method is to move the entire linac (the current system allowing this has the linac attached to a robotic arm) to follow tumour movements.

Gated radiation therapy from 2003. Motion adaptive radiation therapy in development

Yes

Adaptive Radiation Therapy

Target tracking treatment tool. Various strategies are implemented to manage changes in cancer size/shape over the course of treatment

Adaptive radiation therapy systematically manages changes in the cancer size that occur during the radiation therapy course. Adaptive radiation therapy represents a variation of standard radiation therapy, where a “pre-designed adaptive strategy” replaces the typical single “pre-designed plan”. That is, multiple plans are used as the cancer responds during the course of treatment.

Early 2000s Yes

Brachytherapy Conventional high dose rate (HDR) and low dose rate (LDR) radioactive source based brachytherapy, low energy and high dose rate electronic brachytherapy, intra-operative brachytherapy

Conventional brachytherapy uses a radioactive source and automatic afterloader whereas electronic brachytherapy utilises a miniature low energy X-ray tube.The source or miniature low energy X-ray tube is inserted into a pre-positioned applicator within body/tumour cavities or on the skin surface to deliver high doses to target tissues while maintaining low doses to non-target tissues.

Experience has shown brachytherapy to be a valid treatment option for many types of cancer, however there are few randomised trials directly comparing brachytherapy with external beam radiation therapy.

1901 Yes

Particle Therapy 3D conformal proton therapy, intensity modulated proton therapy (IMPT), heavy Ion therapy

Particle beam therapy is a form of external beam radiation treatment that uses heavier particles (such as protons or carbon ions) instead of electrons or X-rays. The physical characteristics of particle therapy beam allow the radiation oncologist to more effectively to treat certain types of cancer and other diseases by reducing the radiation dose to nearby healthy tissue. Particle therapy is used in unique clinical situations.

ASTRO Emerging Technologies Committee Evaluation of Proton Beam Therapy: “There is reason to be optimistic about the potential developments in proton therapy and the prospective research that is ongoing at centres worldwide. In all fields, however, further clinical research is needed and should be encouraged. The paediatric solid tumour population potentially has the most to gain from more widespread use of PBT because of the potentially devastating side effects of impaired growth and function, the increased risk of second malignancies, and the high likelihood of cure.”

First patient treated with protons in 1961, first hospital based cyclotron late 1980s

No

Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and his/her doctor.

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APPENDIX II: RADIATION ONCOLOGY DELIVERY TECHNOLOGIES

Image Guided Radiation Therapy (IGRT)Image-guided radiation therapy (IGRT) is the process of frequent two, three and four-dimensional imaging that is captured as close as possible to the time of treatment. The gold standard is image-guidance during treatment beam-on but there is no technology currently commercially available. Positioning correction based on images is done before treatment delivery. It is used in many treatment sites and should be available in every radiation therapy department. Greater use of imaging is required to safely deliver increasingly complex treatments.

2D Megavoltage and Kilovoltage IGRT In Australia, IGRT has been recognised for the Medicare Benefits Schedule (MBS) funding. Megavoltage (MV) image guidance is achieved by capturing an image using an electronic portal imaging panel mounted to the linear accelerator using the treatment beam. 99.5% of linear accelerators in Australia and 100% in New Zealand are equipped with Electronic Portal Imaging (EPI). To utilise EPI for IGRT, the linear accelerator must have an on board imaging system. This consists of a retractable megavoltage detector array that can be placed directly opposite gantry (source of the X-rays) when the patient is in the treatment position on the linear accelerator. Immediately prior to delivery of the fraction of radiotherapy, a 2D image is obtained with the passage of an X-ray beam from the gantry that passes through the intended treatment area of the patient. The beam that exits the patient is then captured on the detector placed on the other side of the patient. The information obtained allows the correct placement and delivery of the treatment for that day. EPI IGRT can be utilised daily but only provides information in 2D format. The quality of the image is also less defined compared to kilovoltage IGRT.

2D Kilovoltage IGRT requires the linear accelerator to have a kilovoltage X-ray tube (attached at 900 to the linear accelerator gantry) and corresponding kilovoltage detector panel (attached at 2700 to the linear accelerator gantry) to capture images. Similar to 2D Megavoltage IGRT, immediately prior to delivery of the fraction of radiotherapy, a 2D image is obtained with the passage of an X-ray beam from the kilovoltage X-ray tube that passes through the intended treatment area of the patient and the beam is captured on the detector placed on the other side of the patient.

The 2D kilovoltage images obtained provide much better definition of bony and some soft tissue structures compared to 2D megavoltage EPI. This can lead to better targeting of the intended treatment volume. The absorbed dose of 2D kilovoltage IGRT is also less than 2D megavoltage EPI. The cost of kilovoltage is higher than 2D megavoltage EPI as it requires additional more modern equipment. 77.2% of linear accelerators in Australia and 80.6% in New Zealand are equipped with Kilovoltage imaging.

3D Kilovoltage IGRT (Cone-beam IGRT) and 4D IGRT Similar to 2D Kilovoltage IGRT, 3D Kilovoltage IGRT requires the linear accelerator to have a kilovoltage X-ray tube (attached at 900 to the linear accelerator gantry) and corresponding kilovoltage detector panel (attached at 2700 to the linear accelerator gantry) to capture images. To obtain 3D or volumetric images, the equipment is rotated 360 degrees with the patient in the treatment position on the linear accelerator. This format of images is often referred to as Cone-beam CT images. As this provides good 3D images of the organs and structures, the treatment is more accurately guided to the intended target while helping to minimise the dose to the organs and structures at risk. This is particularly useful where there are deformable target volumes and deformable hollow organs due to variable filling of those structures (e.g. bladder and bowel filling).

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An extension of 3D kilovoltage IGRT is to obtain a series of Cone-beam CT images over a period of time (minutes) during a fraction of treatment to demonstrate the movement of a target within the body due to respiration where the expansion and contraction of the lung cavity causes displacement of a target. Using this information, the treatment beam can be turned on or off depending on the position of the target in relation to its ideal placement. The concept of 4D IGRT is not confined to using kilovoltage on-board imaging equipment attached to the linear accelerators as technological advances from multiple problem-solving programmes have resulted in various vendors developing many advanced systems. (see also the section on “Advanced Imaging for Treatment Planning” and “Motion Management Techniques for Radiation Therapy Treatment” on pages 6&7)

UltrasoundThere are ultrasound systems available for image guidance of radiation therapy that allows automated ultrasound scanning from outside of the treatment room. In the case of prostate cancer, a probe positioned at the patient’s perineum is used to visualise the prostate. Ultrasound can also be used for replanning between brachytherapy fractions to account for movement of the implant. The use of ultrasound may allow localisation of soft tissue targets without the use of ionising radiation. Ultrasound based IGRT is used in treatment of the breast and prostate and further uptake will depend on the results of ongoing studies and development.

MRI guided IGRTThe advantage of MRI as the image guidance tool is that it does not use ionising radiation and as such, reduces the overall radiation dose received by the patient while still allowing for daily on-line 3D imaging. A number of groups are working on this technology, combining a linear accelerator and MRI image guidance in Canada[21], the Netherlands[22] and Australia[23]. A cobalt based radiation treatment system with MRI based image guidance is currently commercially available via Viewray[24] although this system does make some compromises with both the strength of the magnet used for imaging and the use of cobalt-60 rather than linear accelerator based radiation. MRI guided IGRT would be of most benefit in the treatment of lung, abdomen and mobile soft tissue tumours with uptake in Australia and New Zealand depending on further development, research and the production of more advanced MRI-Linac models. MRI for image guided radiation therapy is not currently in use in Australia or New Zealand.

Intensity Modulated Radiation Therapy (IMRT)Fixed beam IMRT with conventional C-arm linacIMRT is a way of delivering radiation therapy that allows the radiation dose to conform more closely to the shape of the tumour by changing the intensity of the radiation beam. The sharp dose gradients adjacent to both targets and organs at risk involved in this technique increase the consequences of any geometric uncertainty, making daily image guidance an essential component of quality IMRT. IMRT is used in many treatment sites and should be available in every radiation therapy department. 94% of linear accelerators in Australia and 83.9% in New Zealand are commissioned to deliver IMRT. In Australia, IMRT has been reconigsed for the Medicare Benefits Schedule (MBS) funding.

Rotational IMRT - C-Arm linac basedRotational IMRT delivers radiation by rotating the linac gantry through one or more arcs with the radiation continuously on. As it does this, beam parameters can be varied. These include: i) the MLC aperture shape, ii) the dose rate, iii) the gantry rotation speed and iv) the MLC orientation. This method of delivering radiation therapy can increase dose conformity to tumours located centrally within the body although it can result in a ‘wash’ of low dose in the healthy tissue surrounding the target. Indications for rotational IMRT are the same as for fixed beam IMRT with evidence of dosimetric advantage of rotational IMRT in head and neck, prostate, brain and SBRT treatment. Rotational IMRT is largely considered to be the natural progression and more efficient use of IMRT. It is superior to fixed beam IMRT for treatment of some cancers but is not anticipated to completely replace this technique. 50.5% of Linear Accelerators in Australia and 74.2% in New Zealand are commissioned to deliver VMAT.

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Helical IMRT - non C-Arm based linacHelical IMRT combines a CT scanner with a radiation therapy delivery system (linac), enabling daily 3D megavoltage imaging with radiation treatment as well as volumetric IMRT. Indications for helical IMRT are similar to rotational IMRT with potential advantages in highly complex and large treatment volumes. It is anticipated that helical IMRT will be available in multiple departments in Australia and New Zealand as an alternative to rotational IMRT using a C-arm linac. Helical IMRT is available via the Tomotherapy system. There are five non C-Arm based linear accelerators delivering helical IMRT in Australia and none in New Zealand.

Hybrid Arc IMRTHybrid Arc is a novel treatment planning approach that combines optimised dynamic arcs with intensity-modulated radiation therapy (IMRT) beams. Hybrid Arc IMRT has the potential to incorporate the benefits of rotational IMRT (reduced treatment time) with fixed beam IMRT (reduced low dose ‘wash’ over healthy tissue) and could be used for many treatment sites depending on the results of further research and development.

Stereotactic Radiation Therapy (SRT), Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT)/Stereotactic Ablative Radiation Therapy (SABR)SRT/SRS/SBRT/SABR - linac basedRadiosurgery allows non-invasive ablative treatment of benign and malignant tumours. It is used for tumours and lesions as an alternative to surgery including for those in patients that are not surgical candidates due to comorbidities. SRS is used in the treatment of brain, spine, lung and liver tumours as well benign tumours and conditions. Frameless treatment is an option with linac based cranial SRS, meaning that invasive headframes are not required. Stereotactic body radiation therapy/stereotactic ablative radiation therapy use stereotactic principles to treat lesions throughout the body[25]. In Australia, the current MBS item reflects single treatment SRS rather than fractionated SRT. Linac based stereotactic treatment is available in 20 radiation therapy facilities in Australia and 2 in New Zealand.

SRT/SRS - cobalt basedCobalt based radiosurgery uses approximately 200 Cobalt-60 sources to stereotactically treat brain cancers and benign brain conditions. Cobalt based stereotactic treatment is available via the Gamma Knife system in one facility in Australia and none in New Zealand.

SRT/SRS/SBRT/SABR - Helical IMRTHelical IMRT can also be used to deliver stereotactic treatment and could be especially useful in the case of larger treatment volumes (in stereotactic body radiation therapy) and multiple treatment targets. Stereotactic helical IMRT gives the ability to treat multiple targets in a single delivery sequence with a single setup and no isocenter shifts. Patient positioning occurs via IGRT using mega-voltage CT scans. Helical IMRT stereotactic treatment is available via the Tomotherapy system. There are five non C-Arm based linear accelerators that are capable of delivering stereotactic treatment in Australia and none in New Zealand.

SRT/SRS/SBRT/SABR - Robotic RadiosurgeryRobotic radiosurgery is designed to treat tumours throughout the body with high precision and continuous image guidance. Robotic radiosurgery can be used in intra– and extra-cranial stereotactic radiation therapy/radiosurgery. Robotic radiosurgery is available via the Cyber Knife system at one facility in Australia and none in New Zealand.

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Advanced Imaging for Treatment PlanningCT scanner with 4D CT software and hardwareFour-dimensional (4D) CT is an imaging technique that provides information regarding organ motion during respiration (the 4th dimension being time). By using this information at the time of planning, we have a more accurate assessment of target shape and trajectory than traditional 3D (static) planning CT scans.[26] The clinical use of 4DCT data is important for optimal IGRT of tumours in the thorax and upper abdomen and should be available to all radiation therapy facilities. 80.8% of radiation therapy facilities in Australia and 90% in New Zealand have in-house access to 4DCT for treatment planning.

PET-CT for fusion with planning CTIn PET-CT, a Positron Emission Tomography (PET) and an X-ray Computed Tomography are combined in a single system, so that images acquired from both devices can be taken sequentially, in the same session and combined into a single co-registered image. Thus, functional imaging (which has poor spatial anatomy) obtained by PET, can be precisely aligned or correlated with CT anatomic imaging. Functional imaging via PET increases the ability of the clinician to both visualise and therefore treat the entire tumour, and also to choose appropriate patients for radiation therapy treatment [27] (it is more sensitive than CT alone in picking up small volume disease). The International Atomic Energy Agency states “At present there is no compelling data to prove that patient outcomes are superior as a result of the use of PET in RT planning. Proving that PET-planning is superior would require a randomized trial in which some patients were randomized to a less accurate staging workup, thereby presenting significant ethical challenges. Nevertheless, in the opinion of the IAEA expert group, radiation therapy planning should be based on the most accurate available assessment of tumour extent. PET/CT may provide the best assessment for cancer patients at this time.” [28] PET-CT scans can be acquired in the radiation therapy facility if this equipment is available, otherwise external diagnostic images can be imported into the treatment planning system.

Magnetic Resonance Imaging (MRI) for fusion with planning CTMagnetic Resonance Imaging (MRI) often plays an important role in defining the location and local extent of disease. It provides a primary imaging role in CNS disease and in some other diseases (e.g. prostate and head and neck cancer). It defines organ or disease extent as well as spinal cord compression more accurately than other modalities. MRI has been shown to be superior to CT in the staging of some tumours and provides superior soft tissue definition compared with CT scans.[29] MRI for fusion with planning CT is indicated for tumours within soft tissue where delineation between target and healthy tissue is difficult to accurately define using CT alone.[30] MRI scans can be acquired in the radiation therapy facility if this equipment is available, otherwise external diagnostic images can be imported into the radiation therapy treatment planning system (it is, however preferable for images to be acquired in the treatment position). The ‘Imaging in Radiation Oncology – A RANZCR Consensus White Paper’ publication describes the tumour sites for which MRI is an appropriate tool for diagnosis and staging as well as for treatment and planning. It should also be noted that for some tumour sites there are limits or restrictions regarding MBS reimbursement in Australia. An example of this is the limit of one MRI for gynaecological and rectal cancers and no reimbursement is available for MRI of prostate cancer. Currently there is significant work being undertaken looking at defining optimal MRI sequences (software involved with image acquisition and manipulation) and functional imaging in radiation therapy, both in treatment planning and treatment responses. All this is aimed at better targeting the target, regions of the target and adjacent normal organs.

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UltrasoundWith ultrasound, the contour of the patient as well as the location and depth of tumours and normal structures can be visualized and recorded. 3D ultrasound imaging is non invasive and does not require any radiation for generation of images. Ultrasound information can be incorporated into treatment planning, either as a primary or secondary imaging modality. Utilising 3D ultrasound for brachytherapy planning can allow plans to be prepared in real-time [31] (while the ultrasound images are being acquired).

SPECT-CTSPECT-CT is a nuclear medicine tomographic imaging technique that uses gamma rays. It is similar to conventional nuclear medicine planar imaging using a gamma camera, however it is able to provide true 3D information. Whereas PET imaging shows a 2D representation of a 3D structure (in the same way that a plain X-ray does), SPECT shows a true 3D image and allows accurate localisation in space. SPECT-CT provides information about localised function in internal organs and future uptake will depend on the results of ongoing development and studies.

PET hypoxia imagingTumour hypoxia is an important contributor to radioresistance, and increasing the radiation dose to hypoxic areas may result in improved locoregional control.[32] Tracers are being refined that allow accurate detection of hypoxic tumour subvolumes using PET imaging. Current tracers that are used to identify hypoxic cells are characterised by slow tracer retention and clearance, resulting in low inter-tissue contrast. Refinement of tracers will allow increased uptake of this technology.

PET-MRIIntegrated PET/MRI scanners combine anatomic with functional imaging and may have a specific impact on the staging and treatment of head and neck cancer. Advantages of the PET-MRI system over current MRI and PET-CT systems include simultaneous imaging, reduced radiation dose, and increased soft tissue contrast. In tumour sites such as oropharyngeal and oral cavity tumours, integrated PET/MRI scanners may further improve the accuracy of GTV delineation. In addition, dynamic MRI studies such as dynamic contrast-enhanced MRI and blood oxygen level–dependent MRI, as well as MR spectroscopy, may add complementary functional information. PET-MRI combines the superior anatomical definition of MRI with the functional information of PET and uptake will depend on the results of ongoing development and studies.

Motion Management Techniques for Radiation Therapy TreatmentGated radiation therapy - planning, treatment and respiration monitoring system with gating capabilityIn gated radiation therapy treatment, the delivery of radiation is based on the anatomic location of the tumour throughout the breathing cycle (with this information collected via Four Dimensional Computed Tomography (4DCT) or other method). Using gating software, a specific window in the breathing cycle is defined when it is optimal to turn on the radiation beam. Gated radiation therapy can be used in treatment of lung, breast and liver, with further uptake depending on the results of development and studies [33] [34].

Motion adaptive radiation therapyIn motion adaptive radiation therapy, the multileaf collimators are moved dynamically to track the movement of a moving tumour (e.g. lung). Studies are also underway of motion adaptive treatment in both fixed beam and volumetric arc treatment. Motion adaptive radiation therapy is in development for fixed beam and volumetric arc radiation therapy [35] and is intended for use in the treatment of lung, breast and liver, with further uptake depending on the results of development and studies.

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Adaptive Radiation TherapyAdaptive radiation therapy systematically manages changes in the cancer size that occur during the radiation therapy course. Adaptive radiation therapy represents a variation of standard radiation therapy, where a “pre-designed adaptive strategy” replaces the typical single “pre-designed plan”. That is, multiple plans are used as the cancer responds during the course of treatment. Currently, adaptive radiation therapy (ART) remains labour and resource intensive. As ART clinical outcomes mature and the incorporation of volumetric imaging into ART becomes increasingly sophisticated, it is possible that ART will evolve and become a commonplace approach for head and neck and a variety of other radiation treatments.[36] The optimal frequency of assessment of treatment response and the ultimate clinical impact of ART remains to be defined. Adaptive radiation therapy is optimally used in either treatments in which the target size and shape can change on a daily basis, such as bladder radiation therapy, or in treatments in which the tumour is located in close proximity to critical structures that may move into the high dose region over the course of treatment due to tumour shrinkage such as head and neck radiation therapy.

BrachytherapyPermanent Low Dose Rate (LDR) Implant BrachytherapyUses low dose rate radioactive seeds that are implanted into the treatment target. This method can be used to treat an intact structure (e.g. Prostate) or surgical cavity (e.g. Breast). This method of treatment is an accepted treatment option for men with low risk prostate cancer. [37] LDR permanent implant brachytherapy requires further clinical trials to show that this is equivalent to other breast cancer treatments. This method of treatment could be very beneficial to those patients that do not live in close proximity to a radiation therapy facility. There are 18 radiation therapy facilities offering low dose rate brachytherapy in Australia and 2 privatecentres in New Zealand also offer the LDR brachytherapy.

Electronic Brachytherapy (EBT)Electronic brachytherapy (EBT) uses a miniature low energy X-ray tube instead of traditional brachytherapy sources made of radioactive substances. This is inserted into a pre-positioned applicator within body/tumour cavities or positioned on the skin surface to deliver high doses to target tissues while maintaining low doses to non-target tissues.

5-year results of the TARGIT-A trial using the INTRABEAM® device have shown that TARGIT concurrent with lumpectomy could be considered an equivalent alternative to postoperative EBRT in patients selected per the TARGIT-A protocol,[38] however longer term follow-up is required before this can be considered a standard treatment option. Patient preference studies[39] and feedback from consumergroups show that there are patients that would opt for this treatment, given its convenience, even if there was an increased risk of recurrence when compared with postoperative EBRT.

This treatment has been approved by MSAC for reimbursement. One facility in Australia and one in New Zealand currently deliver electronic brachytherapy using the INTRABEAM® device.

It is the Faculty position that this technology is not supported by sufficient evidence to form a definitive view. If this device is to be used patients need to be informed that the TARGIT-A trial follow-up data is short and that with longer follow-up there may be an increased risk of recurrence, late side effects and worse cosmesis.

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Directional BrachytherapyDirectional brachytherapy uses 125I, a low-energy source that delivers a low dose to adjacent tissue. One consequence of using a low-energy radionuclide is that it can be shielded with a thin layer of high-Z material (such as lead or gold), a feature that enables the integration of an internal radiation shield within the source itself. The resulting directional source offers reduced radiation intensity in the shielded direction, while maintaining a similar dose distribution as a conventional brachytherapy seed on the unshielded side. The shielded source used in directional LDR brachytherapy may also enable treatment of breast tumours closer to the surface or chest wall, for example, as well as larger lesions and tumours in smaller breasts than is possible for conventional LDR seed brachytherapy. This is an investigational treatment and uptake will depend on further development and the results of clinical trials.

Particle TherapyProton Therapy - 3D Conformal and scanning beamProton beam therapy is a form of external beam radiation treatment that uses protons rather than electrons or X-rays. Another term for particle beam therapy is hadron therapy. The physical characteristics of the proton therapy beam allow the radiation oncologist to more effectively treat certain types of cancer and other diseases by reducing the radiation dose to nearby healthy tissue. Proton therapy is used in unique clinical situations. Very high intensity laser proton therapy units are in development [40] as well as new small proton machines that have become clinically available requiring significantly reduced capital expense and space considerations than current conventional proton therapy equipment [41]. Pencil-beam scanning is a dynamic beam-delivery system in which a proton beam is actively scanned throughout the target tumour volume providing improved three-dimensional conformity to the target. During a treatment, the transverse beam position, longitudinal beam position (range) and dose are controlled and adjusted to deliver the prescribed dose in the target. A further benefit of pencil beam scanning proton therapy is its use in patients with recurrent disease, who have already received full doses of radiation. In this case, pencil beam limits or eliminates radiation to these already treated areas.[42] This technology continues to build on the patient benefits already offered with proton therapy – more targeted, higher tumour dose, shorter treatment times, reduced side effects and increased treatment options. Proton therapy is indicated for in the treatment of paediatrics, sarcomas and tumours of eye and base of skull [43] with current and future indications included in the “Faculty of Radiation Oncology Proton Therapy Position Paper.” As of 2014 there were over 50 proton and heavy ion therapy centres around the world, with as many as 40 additional facilities being either proposed or under construction.[44] A number of patients are sent each year from Australia and New Zealand to international proton therapy facilities in cases where this treatment is proven to be beneficial.

Proton Therapy - Intensity Modulated Proton Therapy (IMPT)Intensity Modulated Proton Therapy (IMPT) modulates the intensity of the proton beam in a similar way to an IMRT photon beam. This technological advancement makes proton therapy applicable to more disease sites and overcomes some of the limitations of conformal proton therapy [45]. IMPT technology is especially beneficial for larger and complex tumour shapes, such as head-and-neck tumours, tumours of the lower abdomen that have a curved shape and tumours wrapped around the spinal cord or brain stem. IMPT can shape complex fields with a limited number of radiation angles, which keeps the treatment time as short as possible and helps to spare healthy tissue.

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Heavy Ion TherapyHeavy ion therapy utilises particles more massive than protons or neutrons, such as carbon ions. The biological advantages of carbon compared to protons means that the efficiency of the dose is increased by a factor between 1.5 and 3. Heavy ions are preferable to photons for both physical and biological characteristics: the Bragg peak and limited lateral diffusion ensure conformal dose distribution, while the high relative biological effectiveness and low oxygen enhancement ratio in the Bragg peak region make the beam very effective in treating radio-resistant and hypoxic tumours. Results coming from Japan [46] and Germany [47] provide strong clinical evidence that heavy ions are an extremely effective weapon against cancer. However, more research is needed, especially on optimisation of treatment planning and risk of late effects in normal tissue, including secondary cancers.

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APPENDIX III: RELATED INNOVATIONS

Part A – Used in Radiation TherapyFiducial MarkersTo ensure improved accuracy of delivery of radiation therapy, fiducial markers can be implanted into the target (tumour or tumour bed), and their position is checked via imaging immediately prior to treatment each day. Any deviation from the desired set-up is corrected. Fiducial markers can be passive, such as metal seeds identified by X-ray, or active, containing radiotransmitters that broadcast their location to an external receiver. This ensures that the target is treated with the correct dose each day but importantly, also minimises radiation dose to the adjacent normal tissues. Newer generation fiducials made from carbon coated ceramic and stainless steel are being introduced [48] that are intended to reduce dosimetric effects of the implanted fiducials. Image guided radiation therapy (IGRT) utilising daily on-line verification of tumour position or surrogate such as fiducial markers has been shown to reduce systematic and random treatment errors, decreases the risk of geographic miss (for a given margin), and may allow for some reduction in PTV margins. Fiducial Markers are used in the treatment of mobile tumour sites, for example, prostate, lung, liver, and breast. Fiducial Markers are currently used as a standard practice in many facilities in Australia and New Zealand.

Hyperthermia: local, regional or whole bodyHyperthermia used in the treatment of cancer used as an adjunct to treatments such as radiation therapy and chemotherapy. It involves raising the temperature of tumour-loaded tissue to 40-43oC.[49] Hyperthermia may make some cancer cells more sensitive to radiation or harm other cancer cells that radiation cannot damage. When hyperthermia and radiation therapy are combined, they are often given within an hour of each other. Hyperthermia can also enhance the effects of certain anti-cancer drugs. Although many clinical trials have been conducted to evaluate the effectiveness of hyperthermia, this treatment has not been widely adopted [50]. Hyperthermia is used in a small number of facilities in Australia in combination with other therapies for cancer of the cervix, neck and head, lungs, stomach, oesophagus, breast and liver. Further uptake will depend on the results of ongoing studies.

Target/OAR separation (Inert gel or rectal device)Target/OAR separation is used in treatment of the prostate, to increase the space between the prostate and rectum. The separation of target and organ at risk is achieved by the insertion of various inert substances injected between the rectum and prostate or by a rectal device inserted for each treatment to reduce overall dose to rectal tissue during prostate radiation therapy. Both rectal devices and insertion of inert substance are used in Australia. Further uptake will depend on the results of ongoing studies.

Fluorescent Tumour ImagingFluorescent tumour imaging is an investigational imaging method that uses proteins that allow visualisation, in real time, of tumour cell mobility, invasion, metastasis and angiogenesis. These multi-coloured proteins have allowed distinction of healthy tissue from tumour with single-cell resolution. Visualisation of many aspects of cancer initiation and progression in vivo should be possible with fluorescent proteins. Research is ongoing in animal studies [51] and this method of tumour visualisation is starting to be used in human trials [52]. This is potentially of great interest. Uptake of fluorescent tumour imaging for staging, surgery, radiation therapy treatment planning and follow-up will depend on the results of ongoing studies.

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Part B – Associated TreatmentsSelective Internal Radiation Therapy (SIRT)In Selective Internal Radiation Therapy (SIRT), microscopic resin microspheres (SIR-Spheres) that are impregnated with a beta radiating isotope yttrium 90 are injected into the hepatic artery supplying blood to the liver tumours. The SIR-Spheres are then trapped in the vascular bed ofthe tumours where the beta radiation is released.

Completed trials have demonstrated the efficacy and safety of SIRT [53] in treating secondaryliver tumours from various primary tumours including bowel cancer and neuroendocrine. In addition, an increasing number of publications have demonstrated reductions in tumour sizes with SIRT in primary liver cancer. This procedure is undertaken in multiple facilities in Australia and New Zealand in the Radiology department, by Interventional Radiologists in the treatment of hepatocellular (liver) carcinoma and liver metastasis. There is also increasing use in primary and metastatic renal cancers as well as osteoid osteomas and some lung cancers.

Radium 223 ChlorideRadium-223 (Alpharadin) is a first-in-class alpha-pharmaceutical. It targets bone metastases with high-energy alpha-radiation of extremely short range that spares bone marrow. Radium is similar to calcium in that it sticks to bone, and particularly to where new bone is being formed, so it is a highly effective way of delivering radiation to a bony target.[54] This procedure is undertaken in the Radiology department, by Interventional Radiologists in the treatment of castration resistant prostate cancer and associated bony metastases.

Radiofrequency AblationIn radiofrequency ablation, a needle-like RFA probe is placed inside the tumour. The radiofrequency waves passing through the probe increase the temperature within tumour tissue, destroying the tumour. This procedure is performed under image guidance. RFA is considered mainstream in selected liver patients with hepatocellular carcinoma and liver metastasis with evidence in phase II and III studies. There is also emerging use of RFA in the treatment of spinal metastases, with a device (STAR Tumour Ablation System) currently under assessment by HealthPACT in Australia. Ablative treatments using heat are susceptible to what is known as the “heat sink phenomenon” whereby major blood vessels draw heat away from the treatment area. As a result, tumour cells that are next to the blood vessel cannot get hot or cold enough to achieve cell death. It is likely that liver SBRT will ultimately need to be trialled against this technology. This procedure is undertaken in multiple facilities in Australia and New Zealand in the Radiology department, by Interventional Radiologists in the treatment of hepatocellular (liver) carcinoma and liver metastasis.

Microwave AblationMicrowave ablation is a procedure that uses heat from microwave energy to destroy cancer cells. It is mainly used to treat cancer that has spread to the liver from other parts of the body, usually from the colon or rectum. Ablative treatments using heat are susceptible to what is known as the “heat sink phenomenon” whereby major blood vessels draw heat away from the treatment area. As a result, tumour cells that are next to the blood vessel cannot get hot or cold enough to achieve cell death. The heat-sink phenomenon is less of a problem with Microwave ablation compared to Radiofrequency ablation. This procedure is undertaken in multiple facilities in Australia and New Zealand in the Radiology department, by Interventional Radiologists in the treatment of liver, lung, kidney, breast, bone, pancreas and adrenal glands.

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MR Guided focused ultrasound surgery (MRgFUS)MR-guided focused ultrasound surgery (MRgFUS) is an emerging technology with the potential to disrupt traditional treatment techniques across a wide variety of surgical and medical disciplines. Proposed applications for MRgFUS are increasing and include indications as diverse as tumour ablation [55], thrombolysis, haemostasis, reversible blood-brain barrier disruption, targeted drug delivery, gene therapy, and neuromodulation. Based on the low-level, preliminary evidence currently available it would appear that MRgFUS might be a useful tool for the treatment of patients with tumours who may have limited treatment alternatives available to them. HealthPACT assessed this technology in 2011 and an update to this assessment was published in November 2013. This updated assessment found that the technology is still immature and that further research should be published before any recommendation can be made.[56] This procedure is undertaken in a small number of radiology departments inAustralia and none in New Zealand, by Interventional Radiologists in the treatment of thebrain, liver, bone, breast and prostate.

NanoparticlesNanoparticle-aided therapy is currently being investigated and considered for a number of therapeutic approaches in oncology for drug delivery, photodynamic therapy, hyperthermic therapy and radiation therapy. As a targeted contrast agent, drug delivery system or radiosensitizer, nanoparticles could be applicable to many facets of cancer diagnosis, staging and treatment. This is currently an area of significant research worldwide and has the potential to be of great interest. Future uptake will depend on the results of ongoing studies.

Auger Electron TherapyAuger electron emitters (such as 99mTc, 111In, 123I and 125I) decay and emit extremely low energy electrons. This very low energy means that the radiation travels only nanometres and using tumour-seeking nanoparticles bound to Auger electron emitters would enable treatment of tumours at the cellular level. Research is ongoing in both animal and human studies. The great advantage of this treatment would be low normal tissue complications due to the very low penetrating power of this treatment. This is an area of worldwide investigation, and uptake will depend on the results of ongoing studies.

MicrobeamMicrobeam radiation therapy (MRT), is a form of experimental radiosurgery of tumours using multiple parallel, planar, micrometres-wide, synchrotron-generated X-ray beams (‘microbeams’), and has been show to safely deliver radiation doses to contiguous normal animal tissues that are much higher than the maximum doses tolerated by the same normal tissues of animals or patients from any standard millimetres-wide radiosurgical beam. Animal studies [57] have shown that this form of radiation is remarkably well tolerated by normal tissue, but can destroy entire tumours. However, the fundamental biology of MRT remains a mystery and is the focus of research in Australia and internationally. Microbeam treatment would theoretically be appropriate for small tumours currently treated steretoctically and is an area of worldwide investigation. Uptake would depend on the results of ongoing studies.

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APPENDIX IV: GLOSSARY

Brachytherapy A type of radiation therapy where radioactive substances are positioned adjacent to, or surgically implanted into the tumour to deliver radiation; also called internal radiation therapy.

Brachytherapy is commonly used as an effective treatment for cervical, prostate, breast, and skin cancer and can also be used to treat tumours in many other body sites

External Beam Radiation Therapy

The most common form of radiation therapy, which directs the radiation at the tumour from outside the body. With external beam radiation therapy, the dose is usually delivered by a linear accelerator, which can produce radiation beams from different angles by rotating the accelerator “arm” (the gantry).

Helical Intensity Modulated Radiation Therapy (IMRT)

An external radiation therapy technique to deliver therapeutic doses of radiation to a tumour or cancer inside the body.

The term ‘helical’ is used to indicate the fact that both the gantry and the couch move during helical tomotherapy, while standard external beam radiation therapy from a linear accelerator involves only the movement of the gantry, not the couch during treatment.

Intensity Modulated Radiation Therapy (IMRT)

Intensity modulated radiation therapy is a radiation therapy technique that allows radiation to be more closely shaped to fit the tumour and spare nearby critical normal tissue.

High Dose Rate (HDR) Brachytherapy

High-dose-rate (HDR) brachytherapy is a technique using a relatively intense source of radiation therapy to deliver a therapeutic dose of radiation therapy through temporarily placed needles, catheters, or other applicators.

HDR brachytherapy is when the rate of dose delivery exceeds 12 Gray per hour (Gray is the radiation unit of measurement used in radiation oncology). The most common applications of HDR brachytherapy are in tumours of the cervix, oesophagus, lungs, breasts and prostate.

Horizon Scan In this context, a specialised and distinct activity which reviews current, evolving and emerging techniques and technologies in the radiation oncology sector.

HybridArc Intensity Modulated Radiation Therapy (IMRT)

A radiation therapy technique that allows radiation to be more closely shaped to fit the tumour and spare nearby critical normal tissue. This technique combines the benefits of fixed beam and rotational IMRT.

kV Imaging Kilovoltage X-rays used to take films closer to diagnostic quality and for fluoroscopy.

Linear Accelerator (Linac) The device most commonly used for external beam radiation treatments for patients with cancer.

The Linac is used to treat all parts/organs of the body. It delivers high-energy X-rays to the region of the patient’s tumor. These x-ray treatments are designed in such a way that they deliver radiation to cancer cells while sparing the surrounding normal tissue.

The Linac is used to treat all body sites, using conventional techniques, Intensity-Modulated Radiation Therapy (IMRT), Image Guided Radiation Therapy (IGRT), Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation therapy (SBRT).

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Low Dose Rate (LDR) Brachytherapy

LDR brachytherapy treatment involves permanently or temporarily implanting radioactive seeds into or adjacent to the tumour, killing the cancer cells by damaging their ability to divide and grow.

LDR brachytherapy involves radiation sources that emit radiation at a rate of up to 2 Gray per hour. LDR brachytherapy is commonly used for cancers of the prostate, cervix, oral cavity, oropharynx, and sarcomas.

Margin Although patient set-up and stabilisation are used to minimise set-up variations and organ motion, there will always be some uncertainty left. Therefore, safety margins must be applied around the tumour during treatment planning.

MV Images Megavoltage images (images taken on the Linac)

Organs at Risk (OAR) Organs at Risk. Normal tissue close to and/or along the treatment pathway. Minimising radiation dose to these structures improves the toxicity profile and maximises organ function and therefore quality of life following radiation therapy.

Palliative Treatment Treatment for symptom control, not with a curative intent

Radiation Oncologist (RO) A radiation oncologist is a medical specialist who has specific postgraduate training in radiation cell biology and management of patients with cancer, in particular involving the use of radiation therapy (also called radiotherapy) as one aspect of their cancer treatment. They also have expertise in the treatment of non-malignant conditions with radiation therapy.

Radiation oncologists work closely with other medical specialists, especially surgeons, medical oncologists, pathologists, radiologists (diagnostics) and palliative care physicians, as part of a multidisciplinary team caring for patients with cancer.

Radiation Oncology Medical Physicist (ROMP)

A Medical Physicist has substantial tertiary qualifications in physics and applies their knowledge of the principles of physics to the care of patients.

Radiation oncology medical physics is the application and development of the principles and techniques of physics for the therapeutic use of ionising radiation.

Radiation Therapist (RT) The Radiation Therapist is an allied health professional who works in the field of radiation oncology. Radiation therapists plan and administer radiation treatments to cancer patients.

Radical Treatment Treatment with a curative intent

Radiation Therapy A treatment for cancer and a number of non-malignant conditions, which uses highly precise doses of radiation to kill abnormal cells while minimising doses to the surrounding healthy tissue. It has a major positive impact on local cancer control and is a highly effective therapy for control of cancer symptoms such as pain.

Stereotactic Body Radiation Therapy (SBRT)/Stereotactic Ablative Body Radiation Therapy (SABR)

SBRT/SABR (both interchangeable) is a technique designed to deliver radiation therapy very precisely to tumours anywhere in the body. The word stereotactic pertains to the precise positioning of a tumour in relationship to the body. The technology used in SBRT/SABR allows external beam radiation to be delivered with pinpoint accuracy.

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Stereotactic Radio-Surgery (SRS)

SRS is a special form of radiation therapy – it is not surgery. SRS allows precisely focused, high dose X-ray beams to be delivered to a small, localized area of the brain.

The radiation dose per treatment is usually higher (hence more damaging) and much more precise, resulting in fewer treatments necessary than traditional radiation therapy.

It is used to treat small brain and spinal cord tumours as well as blood vessel abnormalities in the brain and neurologic problems such as movement disorders. SRS principles are also utilised to treat certain small tumours in the liver, spine and lungs with Stereotactic Body Radiation Therapy (SBRT).

Stereotactic Radiation Therapy (SRT)

SRT is a form of external radiation treatment used to eradicate cancerous growths. With SRT, a series of precise radiation beams are aimed at a tumour from many different directions.

Stereotactic Radiation Therapy (SRT) utilises the principles of Stereotactic Radiosurgery for localisation, and fractionation regimes that are based on conventional external beam radiation therapy.

SRT often is used to treat cancers in the radiation-sensitive areas of the brain, head and neck — but it can often be used in other locations where radiation is effective.

Target Area where the radiation beams are aimed; usually a tumour, malformation, or other abnormality of the body.

Three Dimensional (3D) Imaging

Three-dimensional (3D) Imaging in radiation therapy treatment is localisation of the target by comparing a cone-beam computed tomography (CBCT) dataset with the planning computed tomography (CT) dataset from planning.

Treatment Planning The process in which a team consisting of radiation oncologists, radiation therapist and medical physicists plan the appropriate external beam radiation therapy or internal brachytherapy treatment technique for a patient with cancer.

Two Dimensional (2D)Imaging

Two-dimensional (2D) Imaging in radiation therapy treatment is localisation of the target by matching planar kilovoltage (kV) radiographs fluoroscopy or megavoltage (MV) images with digital reconstructed radiographs (DRRs) from the planning CT.

Volumetric Modulated Arc Therapy (VMAT)

VMAT is a new type of intensity-modulated radiation therapy (IMRT) treatment technique that uses the same hardware (i.e. a digital linear accelerator) as used for IMRT or conformal treatment, but delivers the radiation therapy treatment using rotational or arc geometry rather than several static beams.

ACKNOWLEDGEMENTTo Michael Bailey for introducing the concept of Radiation Oncology Techniques vs. Technologies.

To Aimee Lovett for researching and writing much of this report.

To Natalia Vukolova, A/Prof Chris Milross, Dr Dion Forstner and Dr Carol Johnson who have been invaluable in writing and editing the document.

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