You’ve Just Been Invited to Participate in a Clinical Trial with Imaging Endpoints – Now What?!

Marybeth Devine, BSRT, CNMTSr. Clinical Program Manager

Lantheus Medical Imaging

04/13/23 2

Presentation Objectives

• Discuss the critical role of Technologists in imaging trials

• Provide strategies for ensuring GCP and protocol compliance in the Nuclear Medicine department

• Discuss the importance of Research Coordinator, Principal Investigator and Technologist interaction and open communication

04/13/23 3

To Ensure a Successful Clinical Study:

• You are already a GOOD investigative site…

• How do you become a GREAT investigative site…– Learn!– Educate!!– Communicate!!!

04/13/23 4

Learn!

• Are your Nuclear Medicine Technologists on board with the study?– REMEMBER: your Research Coordinator is

primarily hired to do research…your Technologists are not!

– If research is a critical component of your department, make sure to hire like-minded Technologists

– …then – support them, make them part of the team and make it FUN!

04/13/23 5

Learn!

• Understand Good Clinical Practice (GCP) and your part in data collection and integrity– Have you and your imaging team attended a

GCP course?– What are “source documents”?– How is it expected the Technologist will complete

the data worksheets?– What is the responsibility of the Research

Coordinator (RC) vs. the Nuclear Medicine team?

04/13/23 6

Learn!

• Understand the imaging endpoint and study procedure flow– How many imaging modalities are there?– Is there a required sequence to study

procedures?– Are there blood draws, ECGs, vitals, EEGs, etc,

which must be obtained concurrently to the imaging procedures?

04/13/23 7

Learn!

• Know the clinical study and site-specific timelines for completion of imaging obligations – the Technologist needs to be involved!– Does the sponsor have an expectation of the timing of first

patient in at your site?– Are their any camera qualification requirements?– Is it necessary to assign one Technologist to “own” the

clinical study?– Are the image submission time line requirements

understood?– When are the blinded reads?– Will there be Data Monitoring Committee meetings

requiring image data submission?

04/13/23 8

Learn!• Understand what data (images, imaging time points, assays,

doses, etc.) will be needed from you– Do you have a list of all the views and imaging time points

needed?– Do you fully understand what is required for image acquisition

(list mode, dynamic, static)– Do you fully understand what is needed for image processing

(filters, etc.)?– Does the Technologist understand their responsibility for image

quality?– Will IT need to be contacted to assist with image transfer via

FTP?– Will there be a sponsor representative with Nuclear experience

onsite for your first subject dosing?– Understand what is “required” and what is “recommended”

04/13/23 9

Learn!

• Identify what, if any, camera qualification and image quality procedures will be needed– Is all the information for camera qualification

readily available?– How quickly does the PI/sponsor expect the

QC procedures to be completed?

Accept that adjustments to existing systems and imaging techniques might be needed!

04/13/23 10

Learn!

• Be open-minded: clinical imaging and research imaging are not necessarily synonymous– How do the acquisition parameters (sequence, set up,

etc.) differ from clinical practice?– How will you ensure the imaging protocol is adhered to?– How will you educate your staff?– What provisions will be made to ensure enough camera

time is available to complete the imaging without jeopardizing image quality and data integrity?

– What other obligations will the Nuclear Medicine staff be undertaking?

– If a certain procedure does not appear to be logical – ask for the rationale

– If in doubt on how to perform a certain procedure – ASK!!!

04/13/23 11

Learn!

Practice the study procedure prior to the first

patient!!!!!

04/13/23 12

Educate!!

• Nuclear Medicine 101 for Research Coordinator and other staff– Do not assume the RC has experience with

Nuclear imaging– Educate on Nuclear Medicine as well as the

specific imaging being obtained for the research protocol (oncology, cardiac, etc.)

– Help the RC understand the uniqueness of Nuclear imaging (radiopharmaceutical half lives, evaluating organ function, etc.)

04/13/23 13

Educate!!

• Offer to review imaging guidelines and data transmittal forms for Sponsor

• Offer imaging protocol advice, but understand where the Sponsor is coming from– Not all Sponsors have an understanding of

Nuclear imaging

• Request Nuclear Medicine Technologist presence at Investigator Meetings

04/13/23 14

Communicate!!!• Communicate questions, issues and

concerns within the group and to the Sponsor– Understanding of the clinical protocol (endpoints)– Difficulties with imaging protocol– Understanding of data transmittal forms– Issues with image download and submission– Difficulties with imaging core lab– Role clarification

04/13/23 15

Communicate!!!• Ensure the Technologists are on board

with the research obligations:– Evenings?– Weekends?– Make it worth their while– Make it fun!

• Make sure the Technologists get to know the Sponsor representatives – they should be at the Site Initiation Visit!!

04/13/23 16

Communicate!!!• Regular meetings with all study staff to

evaluate:– What is working and what isn’t– Where are the log-jams?– Is everyone comfortable with their role?– Does each member of the team feel they have

the resources and training to perform their duties?

– Lessons learned– If you need to replace or remove a member of

the team – DO IT!

04/13/23 17

04/13/23 18

04/13/23 19

04/13/23 20

Summary

• When the imaging study is a primary endpoint of a clinical trial, the Nuclear Medicine Technologist could very well play the most critical role in the success of the investigative site, clinical study and even the approval of investigative product!

• Following GCP guidelines is CRITICAL to the success of any clinical trial. Nuclear Medicine Technologists must be educated on and have a full understanding of GCP.

04/13/23 21

Summary

• Adherence to the clinical trial protocol, as well as the trial-defined imaging protocol, is imperative. The PI should ensure the technologist has a full understanding of both the clinical study and imaging procedures.

• Uncommunicative, disjointed research teams can derail an investigative site quite rapidly. Re-establishing your site’s research reputation can take years as most Sponsor’s are not willing to be burned twice!

04/13/23 22

• A successful clinical trial needs engaged, interactive, coordinated and knowledgeable clinical teams at the investigative sites

• Excellent investigative sites will never lack for research protocols – you are hard to find…so news travels fast!!

Success – Bottom Line