Site Imaging Manual ACRIN 6701

Version: Final Version 1.0

Date: 09‐Oct‐2012

Site Imaging Manual

ACRIN 6701

Repeatability Assessment of Quantitative DCE‐MRI and DWI:A Multicenter Study of Functional Imaging Standardization

in the Prostate

ACRIN6701SiteImagingManual

09Oct2012 pg.1of16

Table of Contents Letter of Introduction ................................................................................................................................. 3

ACRIN 6701 Study Schema .......................................................................................................................... 4

1.0 OVERVIEW OF IMAGING REQUIREMENTS .......................................................................................... 5

2.0 STUDY OBJECTIVES/SPECIFIC AIMS ..................................................................................................... 6

3.0 SCANNER QUALIFICATION ................................................................................................................... 6

3.1 DWI Phantom Scanning ........................................................................................................ 7

3.2 DCE‐MRI Phantom Scanning ................................................................................................. 7

3.3 Qualification Review ............................................................................................................. 7

3.4 Phantom Re‐scan .................................................................................................................. 8

3.5 Qualifying Image Submission ................................................................................................ 8

4.0 Participant Eligibility ............................................................................................................................ 9

4.1 Inclusion Criteria ................................................................................................................... 9

4.2 Exclusion Criteria................................................................................................................... 9

5.0 Participant Scheduling ....................................................................................................................... 10

6.0 Participant Preparation ..................................................................................................................... 10

7.0 Contrast Agent Administration ......................................................................................................... 10

8.0 Standardized Image Acquisition Protocols ........................................................................................ 11

9.0 Image Submission .............................................................................................................................. 11

9.1 TRIAD .......................................................................................................................................... 11

9.2 Image Transmittal Worksheet (ITW) .......................................................................................... 12

10.0 Image Quality Control (QC) .............................................................................................................. 12

10.1 Local Site Review of Imaging .................................................................................................... 12

10.1.1 Site Assessment Specific to MRI Scan 1 .................................................................. 12

10.1.2 Site Assessment Specific to MRI Scan 2 .................................................................. 13

10.1.3 Locally‐Determined Deficient Imaging Study ......................................................... 14

10.2 ACRIN Core Laboratory Quality Control Technical Review ...................................................... 15

10.2.1 Image Data Queries .................................................................................................. 15

10.3 Central Diagnostic Review of MRI SCAN 1 ............................................................................... 15

11.0 Imaging Forms……..………………………………………………………………………………………………………..……………16


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REFERENCES………………………………………………………………………………………………………………………………………17

APPENDIX I: DWI PHANTOM TEST INSTRUCTIONS

APPENDIX II: DCE PHANTOM TEST INSTRUCTIONS

APPENDIX III: MRI SCAN 1 IMAGING PROCEDURES

APPENDIX IV: MRI SCAN 2 IMAGING PROCEDURES

APPENDIX V: MRI IMAGE ACQUISITION PARAMETERS

History of Revisions:


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Letter of Introduction

Dear Imaging Staff,

This Site Imaging Manual contains the image acquisition instructions for the ACRIN 6701 trial:

“Repeatability Assessment of Quantitative DCE‐MRI and DWI: A Multicenter Study of Functional

Imaging Standardization in the Prostate.”

To successfully meet the study objectives, it is critical that the DCE‐MRI and DWI image datasets are

acquired according to the imaging protocol detailed in this manual.

Quality Control (QC) review of the images will be performed by the ACR Imaging Core Laboratory. This

review will be performed in a timely fashion, as part of ACRIN standard operating procedures. If any

protocol deviations or technical issues are identified during the review, an ACR Core Lab Imaging

Technologist will contact your site to provide feedback expeditiously. This will allow your site to make

any necessary adjustments early in the conduct of the study.

The ACRIN 6701 Imaging Team wishes to thank you in advance for your diligence in adhering to the

procedures described in this manual to ensure the integrity of the image data collected for the study.

Please do not hesitate to contact the ACRIN 6701 Imaging Technologist (see contact information

below) if you have any questions.

Sincerely,

Dena Flamini RT(R)(M)(MR)

ACRIN 6701 Imaging Analyst

American College of Radiology

1818 Market Street‐ Suite 1600

Philadelphia, PA 19103

Phone: (215) 940‐8880

Fax: (215) 923‐1737

www.acrin.org

[email protected]


09Oct2012 pg.4of16

ACRIN 6701 Study Schema

42 Day Maximum Timeline from Enrollment to Completion of Both MRI Scans

SOCAnatomicMRIplusStudy‐RelatedDWIScan

andGad‐EnhancedDCE‐MRI#1:

MRIBetween0and28Daysafter Enrollment

Study‐RelatedDWIScanandGad‐EnhancedDCE‐MRI

#2:

MRIBetween2and14CalendarDaysafterMRIScan#1

TREATMENT

Between 0 and 28 days later

Between 2 to 14 days later

Day#0

Eligibility/Enrollment:

Calculate GFR for Renal Function ACRIN Web Registration


09Oct2012 pg.5of16

1.0 OVERVIEW OF IMAGING REQUIREMENTS

DCE‐MRI and DWI

Qualification

Submit prior to site activation (for each scanner):

Protocol Specific Application (PSA)

Submission of phantom‐based DCE‐MRI and DWI qualification exams

(acquired per the ACRIN 6701 standardized imaging protocol).

TRIAD Installation Should be installed prior to study participant enrollment for secure,

electronic submission of imaging to ACRIN.

Time Points

for Trial Examinations

DCE‐MRI and DWI per standardized ACRIN 6701 acquisition protocol

provided in this imaging manual:

MRI/DWI/DCE‐MRI‐1: between 0 and 28 days of enrollment

(at time of standard‐of‐care anatomic MRI per institutional practice)

MRI/DWI/DCE‐MRI‐2: between 2 and 14 calendar days after MRI Scan #1

Image Submission

ACRIN 6701 imaging should be submitted electronically to the ACR Imaging

Core Lab via TRIAD. All imaging should be submitted within 48 hours after

acquisition and should include an Image Transmittal Worksheet (ITW).

Data Queries ACRIN will issue queries, as needed, based on QC review of imaging.

Rescanning With

Phantom for

Maintenance

The qualification phantoms must be rescanned prior to any subsequent

participant scan if there are any substantive changes in scanner hardware or

software during the trial.

General Trial Requirements:

3T whole body MRI scanner

Institutional expertise in prostate MRI (proven record of 50 prostate MRIs per year)

Site must be able to utilize a torso‐array coil

Site must be able to utilize a power injector

The site must perform both study‐related DCE‐MRI and DWI examinations on the same MRI

unit for the same participant using the same magnet configuration (manufacturer; field

strength; coil)

Site must submit all trial exams to ACRIN within 48 hours after acquisition

NOTE: It may be helpful to keep a copy of this Manual in the imaging department, so all

technologists involved in the image acquisition of ACRIN 6701 are privy to the protocol‐required

imaging specifications.


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2.0 STUDY OBJECTIVES/SPECIFIC AIMS

The Quantitative Imaging Biomarkers Alliance (QIBA) dynamic contrast‐enhanced‐magnetic resonance

imaging (DCE‐MRI) committee is working to identify the limits of reproducibility of DCE‐MRI

quantitative metrics critical for useful biomarker studies. The ACRIN 6701 trial will examine the QIBA

DCE‐MRI profile claims regarding the repeatability of tumor DCE‐MRI, as well as repeatability of

diffusion weighted imaging (DWI) metrics, and evaluate the performance of these metrics in human

subjects with prostate tumors. In addition to implementing the imaging protocol, the trial will

introduce site imaging personnel to proper procedures for magnet qualification, the selection of

tumor‐bearing human subjects, and the implementation of the proper DCE‐MRI and DWI parameters

in general oncologic MRI.

Primary Hypothesis

Within the context of a multi‐site clinical trial, the upper limits of the repeatability coefficient (RC) for

DCE‐MRI metrics Ktrans and blood‐normalized initial area under the gadolinium curve (IAUCG90bn), and

DWI metric D(t), using the whole prostate as a target lesion, can be demonstrated to be less than or

equal to the pre‐specified values that signify the minimal detectable significant biologic change of each

quantitative MRI metric.

Hypothesis #1: The repeatability coefficient (RC) of the DCE‐MRI metric Ktrans, as measured by median pixel values of the whole prostate, is equal to or less than 22%.

Hypothesis #2: The RC of the DCE‐MRI metric IAUGC90bn (blood‐normalized initial area under the gadolinium curve between 0 and 90 seconds), as measured by median pixel values of the whole prostate, is equal to or less than 0.05 (in normalized units).

Hypothesis #3: The RC of DWI metric D(t), as measured by median pixel values of the whole prostate, is equal to or less than 0.3 x 10‐3 mm2/sec.

3.0 SCANNER QUALIFICATION

Participation in the ACRIN 6701 requires that all sites adhere to standardized DCE‐MRI and DWI

protocol parameters. The use of standard imaging guidelines is an essential component of clinical

trials in which imaging plays a central role in the research endpoints. This is of particular importance

in multicenter trials where equipment, personnel, and imaging acquisition protocols can vary

significantly. Thus, the use of standardized imaging guidelines helps control the inter‐ and intra‐

variability inherent in multicenter imaging trials.

The purpose of any imaging qualification process is to help ensure the trial imaging is of high quality

and performed per the trial‐standardized acquisition protocol. To participate in the ACRIN 6701 trial,

each site must qualify by first scanning the DWI and DCE‐MRI phantoms based on ACRIN 6701

phantom scanning protocols. Phantom scanning provides an opportunity to evaluate compliance


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with sample imaging acquisition protocols prior to participant recruitment and actual trial‐specific

protocols.

These qualification examinations will be reviewed by the ACR Imaging Core Lab for both protocol

compliance and image quality; approval of the qualification exams is required prior to ACRIN 6701

site activation. Suboptimal image quality and/or imaging not performed per the trial‐standardized

protocol can result in exclusion of the imaging exam(s) and/or the entire case from analysis.

Therefore, routine QC and adherence to the ACRIN 6701 image acquisition protocol are of great

importance, and sites will be asked to re‐scan using the phantoms should there be any substantive

changes in hardware or software to the scanner during the conduct of the trial.

3.1 DWI Phantom Scanning

Prior to site qualification, a DWI phantom test scan must be run. Sites will be provided with a

DWI ice‐water phantom; this phantom consists of a 1.5 liter white plastic container with a

sealed 75ml tube pre‐filled with distilled water. The design of this phantom allows for the

measurement of apparent diffusion coefficient (ADC) values of a known temperature‐controlled

fluid to confirm proper MRI system performance in acquisition of diffusion weighted (DW)

imaging. Upon completion and approval of the DWI phantom qualification testing, sites are

asked to keep the ice‐water phantom in the event that there is a need for DWI phantom testing

re‐qualification.

Please see Appendix I for detailed DWI phantom test scan parameters and instructions.

3.2 DCE‐MRI Phantom Scanning

Prior to site qualification, a DCE phantom test scan must be run to assess MRI system

performance. Sites will be provided a standardized multi‐compartment R1 phantom having

inserts with T1 relaxation times spanning the ranges typically obtained in blood and in tissue.

Sites are to retain the DCE phantom, until the ACR Imaging Core Lab has approved the

submitted imaging; a Core Lab representative will then provide detailed shipping instructions.

Please see Appendix II for detailed DCE phantom test scan parameters and instructions.

3.3 Qualification Review

The qualification exam will be evaluated for image quality (e.g. artifacts, distortion, and

signal‐to‐noise) and compliance with the standardized DCE‐MRI and DWI acquisition protocol.

An ACR Imaging Core Lab Imaging Technologist will notify the site of the results of the

qualification review via e‐mail. E‐mail documentation will include your site’s Study

Coordinator (SC), site PI, and lead technologist to inform the site team whether the qualifying

exams have been approved or not. If the qualifying exams are not approved, required

corrections for rescanning will be included in the e‐mail.

NOTE: Approval of these qualifying exams is mandatory prior to your site registering a

participant onto the ACRIN 6701 trial.


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3.4 Phantom Re‐scan

If DWI or DCE‐MRI initial phantom scans are not approved after initial scanning and submission, phantom re‐scans (DWI or DCE‐MRI) will be required until parameters for approval are met for site qualification. Upon approval of both the DWI and DCE‐MRI phantom scans, no additional requalification is required unless one of the following conditions occurs:

a. New scanner being introduced. A new scanner system, not ACRIN qualified via phantom assessment, is to be used for subsequent patient studies.

b. Major changes to qualified scanner. A major change in scanner hardware or software occurs during the course of the study. This would include major software upgrades (i.e., a software upgrade that result in a new software primary version number) and changes to the coil system, gradient systems, or RF amplifier. Periodic minor updates to existing software versions are not considered major changes.

c. Trial ongoing after one year. If active patient accrual and scanning are underway at one‐year after the date of the original approval of the phantoms for the trial, then requalification will be required, with replicate scanning of the DWI and/or DCE‐MRI phantoms.

NOTE: We strongly encourage sites to use a single 3T MRI scanner for the entire study. However, a second 3T MRI scanner for use in this study may be necessary for some sites. In such cases, qualification—via DWI and DCE‐MRI phantom scanning and approval—is necessary for each scanner to be used in the study. ACRIN strongly encourages that all MRI scans for a given patient take place on the same scanner unless such is not feasible due to temporary scanner failure.

3.5 Qualifying Image Submission

Phantom images in DICOM format are to be sent to the ACR Imaging Core Lab on Compact

Disc (CD) or DVD.

Please label the disk, in permanent marker, with the following information:

Site Name

Trial Name (ACRIN 6701)

Date of Phantom Imaging (DD‐MMM‐YYY)

Type of Phantom Imaging (e.g. DWI or DCE imaging)

For questions related to DCE‐MRI/DWI phantom qualification, please send an email to:

[email protected]. Enter “ACRIN 6701 DCE‐MRI/DWI Qualification” in the subject line.

Ship All Qualification Imaging to:

American College of Radiology

1818 Market St., Suite 1600

Philadelphia, PA 19103

Attn: ACRIN 6701 DCE‐MRI/DWI Qualification


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4.0 Participant Eligibility

4.1 Inclusion Criteria

Men 18 years of age or older

Diagnosis of prostate cancer by trans‐rectal ultrasound (TRUS)‐guided biopsy 28 to 90 days

prior to enrollment

Minimal tumor burden as defined by at least one of the following criteria:

o One single core with ≥ 50% cancer burden and ≥ 5 mm tumor length

o Two or more cores in the same prostate region, each with ≥ 30% cancer burden

o Three or more cores positive for prostate cancer (of any magnitude of cancer

burden) in the same prostate region

o Gleason grade 7 or higher cancer burden

o PSA ≥ 10 mg/mL

4.2 Exclusion Criteria

Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice

Presence of MRI‐incompatible metallic objects or implanted medical devices in body

(including but not limited to: non‐MRI compatible metal objects, cardiac pacemaker,

aneurysm clips, artificial heart valves with steel parts, metal fragments in the eye or central

nervous system)

Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 based

on a serum creatinine level obtained within 48 hours prior to enrollment

Weight greater than that allowable by the MRI table, per local institutional practice

Anti‐androgenic therapy within 30 days prior to enrollment

Prior external beam, proton, or brachytherapy to the prostate

Prior hip replacement or other major pelvic surgery


09Oct2012 pg.10of16

5.0 Participant Scheduling

Participants will undergo two 3T MRI studies for the trial. These quantitative MRI studies (DCE‐MRI and

DWI) will be performed without the endo‐rectal coil. Sites are to follow local procedures for endo‐

rectal coil use during the first MRI, which should be the standard practice anatomical MRI.

MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for

clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to

treatment initiation.

NOTE: The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2. The same

contrast agent used for MRI SCAN 1 must be utilized for MRI SCAN 2.

6.0 Participant Preparation

Prepare participant according to local standard practice, including any pre‐treatment for severe

claustrophobia or anxiety.

Confirm renal function sufficiency prior to imaging (eGFR must be assessed within 48 hours prior to

participant enrollment but does not have to be repeated for the trial as long as scheduling

timelines do not deviate).

Same size and placement of the intravenous catheter is recommended for both MRI scans. Each

participant should have an intravenous catheter with a gauge no smaller than 20 gauge. Ideally,

the injection site that was used for the initial exam (MRI SCAN 1) should be the same for all

subsequent exams for that given patient (MRI SCAN 2) and any additional imaging that may be

required to complete the trial protocol (see protocol Sections 8.3 and 8.4.1 for details). Injection

through a port‐a‐catheter or other permanent indwelling central catheter is not permitted.

The participant will be placed supine in the magnet; arms at side are acceptable. The torso array

coil should be placed about the pelvis per institutional standard practice. Landmark the participant

at the level of the symphysis pubis

Initiate imaging …

NOTE: If institutional standards require the use of endo‐rectal coil for anatomic imaging during MRI

SCAN 1, this should be placed prior to imaging‐ as per intuitional practice. See note regarding the

use of endo‐rectal coil for anatomic imaging in Appendix III‐ Part II.

7.0 Contrast Agent Administration

Each participant should have an intravenous catheter (no smaller than 20 gauge), placed prior to

imaging.

Contrast agent should be administered in a dynamic fashion with a power injector at both test and

re‐test time points.


09Oct2012 pg.11of16

Contrast injection should begin 30‐40 seconds after the start of data acquisition.

For the DCE (3D T1) sequence, gadolinium contrast agent should be administered intravenously at

a dose of 0.1 mmol/kg body weight and rate of 2 mL/second, followed by a 20 mL saline flush,

also at 2 mL/second.

The type, amount, rate of injection, and site/gauge of IV should comply with the study guidelines

and should be documented by the technologist on the MRI Scan Administration form.

NOTE: The gadolinium agents MultiHance, Eovist, and Vasovist are NOT permitted to be used as a

contrast agent for the subjects on this trial. Also, keep in mind that the same brand and dose of

contrast, same IV site, and same rate of contrast and saline flush administration should be

maintained for both the test and re‐test examinations.

8.0 Standardized Image Acquisition Protocols

At each time point, the ACRIN 6701 imaging protocols will include a:

Pre‐contrast T2‐weighted sequence

Pre‐contrast diffusion‐weighted imaging (DWI) SE‐EPI sequence

Pre‐contrast T1 mapping sequence set

Pre‐contrast coil ratio map sequence set

Pre‐/post‐contrast T1‐weighted dynamic contrast‐enhanced (DCE) sequence

Please review the participant preparation description in Section 6.0 above and the following

participant preparation instructions and acquisition parameters carefully as this imaging protocol may

or may not align with your institution’s standard prostate MRI protocol.

NOTE: Additional imaging for clinical staging as per institutional routine may occur during MRI SCAN

1. See Appendices III‐ V for time‐point specific exam sequences.

9.0 Image Submission

9.1 TRIAD

All trial exams will be submitted to ACR Core Laboratory via TRIAD. TRIAD is a software

application that ACRIN provides for installation on a site’s PC. One or several computers of

choice within the institutional “firewall” and on the institutional network may be equipped with

TRIAD software; internet access is also required. The TRIAD application can then be configured

as a DICOM destination on either scanner(s) and/or PACS system for direct network transfer of

study related images into the TRIAD directory. When properly configured, the TRIAD software

anonymizes, encrypts, and performs a lossless compression of the images before they are

transferred to the ACRIN image archive in Philadelphia.

Your site will need to communicate with their IT department for assistance with the initial steps

outlined in the TRIAD Pre‐Installation Checklist (see Appendix VI) prior to scheduling TRIAD


09Oct2012 pg.12of16

installation.

Once equipment‐readiness has been determined, imaging personnel from ACRIN will

coordinate installation and training for the software.

The TRIAD Installation Guide and TRIAD Users Guide can be found online at

https://triad.acr.org/Learning.htm

To contact TRIAD Support call: 215‐940‐8820 or email TRIAD‐[email protected]

9.2 Image Transmittal Worksheet (ITW)

All imaging should be submitted within 48 hours after acquisition and should include an Image

Transmittal Worksheet (ITW). An Image Transmittal Worksheet (ITW) is used during the exam

QC review to verify a complete transfer of images has been submitted to the ACR Imaging Core

Lab. The ITW is completed in the Medidata/Rave data management system and upon the

completion of this form, an email will be automatically generated to the ACRIN Imaging

Technologist to notify an image submission has taken place.

10.0 Image Quality Control (QC)

10.1 Local Site Review of Imaging

10.1.1 Site Assessment Specific to MRI Scan 1

After completion of imaging for MRI SCAN 1, the study should be reviewed based on

standard institutional practices for clinical image review and reporting. This assessment

will include:

Adequacy of endo‐rectal coil placement for anatomic imaging (if applicable)

Proper placement and functional of torso array coils throughout all imaging

sequences

Removal of endo‐rectal coil (if applicable) and proper participant repositioning

and landmarking prior to initiation of non endo‐rectal coil study imaging

sequences

Adequacy of anatomic imaging, especially the axial T2‐weighted series, with:

o proper anatomic prescription to include entire prostate and seminal

vesicles

o acceptable signal‐to‐noise ratio

o absence of severe artifacts that would render the series clinically non‐

diagnostic

Adequacy of DWI imaging, with:

o proper acquisition parameters, including FOV, matrix, phase direction,

slice thickness, and use of fat saturation


vesicles


09Oct2012 pg.13of16

o proper number and choice of B values



diagnostic

Adequacy of DCE‐MRI imaging, with:

o proper acquisition parameters, including FOV, matrix, phase direction

slice thickness, and slice number

o proper anatomic prescription including full pelvic imaging with prostate

located eccentrically in the inferior aspect of the slab to minimize arterial

inflow

o completion of all three aspects of the DCE‐MRI series: T1 mapping, coil

ratio map, and dynamic gadolinium imaging, with proper choices of flip

angle, signal averaging, and number of phases for each

o correct choice of contrast agent type, dose, rate of injection, and timing

of injection



diagnostic

10.1.2 Site Assessment Specific to MRI Scan 2

After completion of imaging for MRI SCAN 2, the study should be reviewed based on

standard institutional practices for clinical image review and reporting. This assessment

will include:

Proper placement and functional of torso array coils throughout all imaging

sequences

Adequacy of axial T2‐weighted series for prostate localization

Adequacy of “pre‐coffee break” DWI imaging, with:




vesicles




diagnostic

Correct implementation of the “coffee break” as evidenced by correct

replacement of torso array coils, repeat landmarking and axial T2W imaging,

repeat localizer imaging, and adequate temporal gap between the two DWI

image sets (minimum of three minutes)

Adequacy of “post‐coffee break” DWI imaging, with:


09Oct2012 pg.14of16




vesicles




diagnostic

Adequacy of DCE‐MRI imaging, with:

o proper acquisition parameters, including FOV, matrix, phase direction

slice thickness, and slice number

o proper anatomic prescription including full pelvic imaging with prostate

located eccentrically in the inferior aspect of the slab to minimize arterial

inflow

o completion of all three aspects of the DCE‐MRI series: T1 mapping, coil

ratio map, and dynamic gadolinium imaging, with proper choices of flip

angle, signal averaging, and number of phases for each

o correct choice of contrast agent type, dose, rate of injection, and timing

of injection



diagnostic

10.1.3 Locally‐Determined Deficient Imaging Study

If the standard practice anatomic sequences of MRI SCAN 1 are deemed suboptimal for

clinical evaluation by the local site imaging team, the site PI/radiologist has the

discretion to recommend repeat of one or more clinical imaging series during MRI SCAN

2. The endo‐rectal coil is not expected to be used for any imaging sequences during MRI

SCAN 2. However, if the local site radiology investigator deems that re‐use of the endo‐

rectal coil per standard institutional practice for repeated clinical anatomic imaging is

desirable, repeat endo‐rectal coil placement is allowed for this portion of MRI SCAN 2.

The recommendation for re‐use of the endo‐rectal this should be adequately explained

to the participant prior to MRI SCAN 2.

Similarly, if the study‐specific DWI and/or the DCE‐MRI sequences of MRI SCANS 1 or

MRI SCAN 2 are deemed technically inadequate or incomplete/not per protocol

specifications, the site PI/radiologist and/or ACRIN has the option to recommend

repetition of the deficient study sequences as a separate visit. Only willing participants

will undergo additional imaging visits.

Any participants unwilling to complete repeat imaging studies will be off‐study and will be replaced to meet trial accrual.


09Oct2012 pg.15of16

Repeat imaging must adhere to the protocol‐specific imaging procedures and performed within 14 days of the non‐deficient imaging study.

The site must appropriately document all cases in which deficient imaging led to repeat of imaging. Contact the trial’s lead ACRIN data manager for assistance as needed.

10.2 ACRIN Core Laboratory Quality Control Technical Review

Upon receipt of the images at the ACR Imaging Core Lab, an initial QC review will be conducted

by a qualified ACRIN Imaging Technologist. The ACRIN Imaging Technologist will check for

missing images/sequences, appropriate image anonymization, complete anatomical coverage

of the prostate, adherence of all sequences to imaging protocol, and absence of image artifact.

In cases where image sets are judged to be suboptimal (“technically inadequate”), the trial PI

will be informed, and a replacement participant will be accrued from participating institution.

10.2.1 Image Data Queries

If it is found during the QC review that the submitted exam has missing data or does not

follow the protocol guidelines, detailed in this manual, the Medidata/Rave data

management system will generate an auto‐query. Sites are expected to resolve data

queries expeditiously. Queries not resolved within 7 business days will be sent to the

ACRIN 6701 trial team for additional follow‐up.

10.3 Central Diagnostic Review of MRI SCAN 1

Prior to quantitative DWI and DCE‐MRI analysis, two central radiologists will each assess for the presence of visible tumor nodules. If central diagnostic evaluation of MRI SCAN 1 by either reader fails to reveal a definite or likely tumor nodule of 5 mm or greater, a replacement participant will be enrolled to the trial

Replacement participants will be enrolled for any of the following reasons

An enrolled participant does not complete all required imaging for MRI SCAN 1 and MRI SCAN 2

Either MRI SCAN 1 and/or MRI SCAN 2 is determined to be technically inadequate, and the inadequate imaging series cannot be obtained during a repeat visit.

MRI SCAN 1 does not reveal at least one definite or probable tumor nodule 5mm or greater as determined by each of two independent central readers.

Replacement participants will be accrued at the same participating site with the same vendor equipment, if the participant whose deficient imaging needs to be replaced (in order to maintain accrual of 10 participants to each vendor manufacturer).


09Oct2012 pg.16of16

Participants with complete MRI SCAN 1 and MRI SCAN 2 imaging data sets, but whose

MRI SCAN 1 does not define a dominant tumor nodule, will still be evaluated for the

non‐tumor endpoints (e.g. whole prostate evaluation for DWI and DCE‐MRI).

11.0 Imaging Forms

There are 5 imaging forms that must be completed and submitted via the Medidata/Rave eCRF system

for each DCE‐MRI and DWI exam.

Image Transmittal Worksheet (ITW)

Imaging Procedure form

MRI Scan Administration

MRI Imaging Assessment‐ Anatomic

MRI Imaging Assessment‐ DWI/DCE MRI

It is recommended that each of the above forms be made available, in hard copy format, for the

Imaging Technologists to be completed during image acquisition when the requested information on

these forms is most readily available. Worksheets of the data asked throughout the various imaging

forms have been created to aid the technologist during imaging and are included in the appendices

of this document.

These Worksheets are meant to approximate the actual ACRIN 6701 screens in the Medidata EDC system (e.g. provide users of the EDC system with the questions asked on the forms within the system). Please note that these are worksheets and are only meant as a HELP TOOL for users who wish to know/prepare for the information content of the e‐CRFs prior to actually logging into the Medidata EDC system.

Note: In the event these worksheets are used, they should be considered source documents and stored in the participant’s medical record. Please do NOT submit the worksheets to ACRIN‐ all participant and image‐related data must be provided electronically in the Medidata database and no hard copy forms/worksheets will be accepted.

ACRIN6701SiteImagingManual AppendixI

MRIDWIPhantomTestInstructions Page1of809Oct2012

Appendix I

DWI Phantom Test Instructions



DWI PHANTOM TEST INSTRUCTIONS

Objective:

Measure apparent diffusion coefficient (ADC) values of a known temperature‐controlled fluid to

confirm proper MRI system performance in acquisition of diffusion weighted (DW) images of

the pelvis using a pelvis/torso array coil.

DWI Ice Water Phantom Preparation Procedure:

Once prepared, an ice water phantom requires approximately 1 hour to reach thermal

equilibrium. Please plan on filling the phantom well in advance of scanning. Once at thermal

equilibrium, the phantom will be usable for several hours. Do not dispose of foam insulation

sleeves and zip‐lock plastic bag shipped with each phantom.

1. The phantom consists of a 1.5 liter white plastic container with a sealed 75 ml tube pre‐

filled with distilled water. Leave the 75 ml tube sealed and affixed within the container.

For phantom preparation, temporarily remove the container from the foam insulation

sleeve and zip‐lock bag.

2. You will need a source of ice cubes or ice chips and a sink basin for phantom filling. The

volume of ice cubes/chips required is approximately twice the volume of the white

container. Fill the white container to the top with ice cubes/chips then add cold tap

water and fill to the top – the colder the water, the better. Loosely cap the phantom for

an initial “cool down period” of approximately 10 minutes.

3. Depending on how cold your tap water is, much of the ice will melt relatively quickly.

Therefore after 10 minutes, reopen the container and pack‐in more ice to replace the

melted ice. Fill ice to the top allowing displaced water to overflow into the sink. The

objective is to have ice cubes to the full depth of the phantom and the interstitial space

filled with water and minimal air (Figure 1). Screw cap on tightly, dry off the phantom

and inspect for leaks.

4. Put the phantom into a foam insulation sleeve with the container top toward the open

end of the sleeve and seal the phantom in a zip‐lock bag. Set the phantom aside for an

additional 50 minutes to allow the central tube to come to thermal equilibrium with

the surrounding ice water. As long as there is adequate ice in the phantom,

temperature will be controlled to near 0°C, thereby holding water within the tube at a



known diffusion coefficient. The phantom should be usable for several hours within the

insulation sleeve. If desired, you can store the phantom in a refrigerator (not a freezer)

to extend the usable time.

5. After scanning, simply empty the ice water down the drain but leave the central tube

filled and sealed for use at a later date by following the same procedure.

DWI Ice Water Phantom Scan Procedure:

1. Set up the DWI phantom in the center of the magnet table, placed upright as shown in

Figure 2a. If appropriate for torso array coil imaging at your center, place posterior torso

coil under the phantom first.

2. Place foam pads or blocks on sides of the phantom to support the anterior torso/pelvic

coil (e.g. see Figure 2). If your system requires additional coil loading, place an appropriate

loading coil adjacent to the phantom. Alternately, a torso type loading coil can be used.

Finally place the anterior torso array coil as shown in Figure 2b.

3. Start a “New Patient/Exam” using the same patient entry convention normally used for

pelvis (non‐eCoil) MRI exams (e.g. “head first, supine”).

4. Keep phantom in the zip‐lock bag and insulation sleeve during the scan procedure to keep

condensate off of MRI system components.

5. If required, wedge or tape the phantom using patient support pads to hold the phantom

firmly in place with the water tube approximately vertical (e.g. parallel to anterior‐

posterior axis) as shown in Figure 1. Precise alignment is not required, although the

phantom should be positioned roughly in the center of the magnet bore.

Overview of Series Required for DWI QC Phantom Scanning:

1. Three‐plane scout/survey

2. Axial 3D T1‐weighted spoiled gradient echo without fat‐suppression

3. Axial DWI using single‐shot echo‐planar‐imaging (EPI) at b‐values=0, 100, 600, 800s/mm2.

Note: A set of DWI containing all 4 b‐values is called one “pass”.



4. “Copy‐&‐Paste” the DWI series and repeat to acquire a total of four passes in immediate

succession in four consecutive series. Avoid changing scanner pre‐scan/hardware settings

between these consecutive series.

Details of Required Series:

1. Three‐plane scout/survey: Use site‐preferred body sequence as used for graphic

prescription of subsequent series.

2. Axial 3D T1‐weighted spoiled gradient echo without fat‐suppression:

FOV = 320mm (A/P phase) x 320mm (R/L frequency) at 256 x 256 matrix.

3. Acquire 4mm slice thickness interpolated to 2mm. Acquire sufficient slices to cover

120mm in the superior/inferior direction. TR=4‐10ms, TE=min, flip angle 10o, single

average, acquisition time <3min.

4. Axial single‐shot isotropic diffusion weighted single SE, echo planar imaging (EPI) by

parameter settings listed in Table 1 below. One DWI “pass” should contain all 4 b‐values.

Copy and paste the DWI series so that 4 consecutive passes are acquired in separate

series. If the MRI system cannot acquire all b‐values in one series, see note in section (e)

under Table 1.

Note: Total scan time for DWI is approximately 4 passes x 3min/pass = 12min.



Table 1. DWI Ice Water Phantom SE‐EPI Scan Parameters

DWI Single‐Shot SE EPI Single Echo

Field Strength 3TDWI Sequence Single‐Shot SE EPI Single Echo Receiver Coil Torso/Pelvis ArrayFOV (mm) 320 RL x 260 APAcquisition Matrix 160 RL x 128 AP *(a)Reconstruction Matrix 256 x 256 *(b)Orientation Axial (Foldover Phase AP; Freq RL)Number of Slices 27Slice Thickness (mm) 5 mmGap (mm) 0TR (ms) >8000TE (ms) 75‐100Half‐scan, Partial‐Fourier, Frac‐NEX No *(a)Number of Gradient Directions 3 orthogonal axes *(c) Freq Enc Bandwidth (Hz/px) 1500 to 2500 *(d)Parallel Imaging Factor (e.g. SENSE) 2 b‐values (s/mm2) 0, 100, 600, 800 *(e) Number Signal Averages 2Fat Suppression On *(f)Image Filtering (e.g. SCIC or CLEAR) Off

(*) Notes

a. Some systems may require “half‐scan”, “partial‐Fourier”, or “fractional‐NEX” in DWI

scans. It is preferred to acquire the full phase‐encode matrix = 120 by setting half‐

scan/ partial‐fourier/fractional‐NEX to “No” or at least as close to 1 as possible.

b. Interpolate image matrix to 256 x 256. Some systems may do this automatically.

c. Acquire DWI along three orthogonal axes so that “isotropic” or “trace” diffusion

weighted images are generated for each slice and b‐value. “Tetrahedral” or

“Gradient Overplus” diffusion encoding schemes are allowed wherein combinations

of X, Y, and Z gradients are applied simultaneously for each orthogonal DWI axis.

Individual diffusion axes DW images are not required. Only the b=0 and DWI trace

images at each b‐value are required.

d. Frequency encoding bandwidth may not be under full operator control. If possible

use “maximum bandwidth”, or equivalently “minimum fat shift per pixel”, or set

within 1500 to 2500 Hz/pixel range.



e. It is preferred to acquire all four b‐values in a single series. The collection of all b‐

values is called one “pass.” However, if on a particular MRI system it is not possible

to acquire all four b‐values in one series, it is allowable to acquire these in three

separate sequential series: b=0, 100 followed by b=0, 600 then b=0, 800. On such

scanners, these three series constitute “one pass.” DO NOT allow TE to change (e.g.

set “OPTIMIZE TE” to “NO”), and do not allow the system to adjust hardware

settings (e.g. transmit/receive gain) between DWI series.

NOTE: The PHANTOM PROTOCOL CALLS FOR FOUR ACQUISITIONS AT EACH b‐

VALUE.

If the scanner acquires all b‐values in a single series, simply repeat the DWI in

four sequential series (e.g. Scan #1 b=0, 100, 600, 800; Scan #2 b=0, 100, 600,

800)…

If the scanner can only acquire one b‐value pair per series, then perform 12

sequential scans in order: Scan #1 b=0, 100; Scan #2 b=0, 600; Scan #3 b=0, 800;

Scan #4 b=0, 100; Scan #5 b=0, 600; Scan #6 b=0, 800; Scan #7 b=0, 100; Scan #8

b=0, 600; Scan #9 b=0, 800; Scan #10 b=0, 100; Scan #11 b=0, 600; Scan #12 b=0,

800.

f. Use site‐preferred spectral fat suppression technique, such as “SPAIR,” but unlike

protocol used on patients DO NOT USE the Inversion‐Recovery fat suppression

technique “STIR” for DWI Phantom scans

ADC Map Generation:

Generate ADC maps for all slices using software tools available on the scanner. The ADC map

should be derived from the full set of b‐values = 0, 100, 600, 800. If the system only acquired

one pair of b‐values in each series, generate the ADC maps using the b‐value = 0, 800 pair. If

possible, take a “screenshot” of a region‐of‐interest (ROI) drawn in a central tube region

showing ROI size/location and resultant statistics (e.g. See Figure 3). The screenshot should be

simply saved within the phantom examination for transfer to ACRIN as DICOM images. Site

certification and QC calculations will be performed on ADC maps regenerated at ACRIN core

labs; however screenshots are helpful to confirm proper image scaling and equivalence in ADC

calculation routines.

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ACRIN6701SiteImagingManual AppendixII

MRIDCEPhantomTestInstructions1of5AppendixII09Oct2012

Appendix II

DCE Phantom Test Instructions



MRI‐DCE QIBA PHANTOM TEST INSTRUCTIONS

Objective:

This document provides information regarding the MRI‐DCE QIBA phantom tests. The QIBA

MRI‐DCE phantom is not currently a commercially available phantom. This phantom will be

provided by ACRIN to all sites for qualification testing purposes only.

Preparing the QIBA DCE Imaging Sequence Templates:

1. Open a protocol or folder labeled “ACRIN6701_DCE_templates.”

2. Create an imaging series using the proper 3D spoiled gradient echo technique based on

MRI manufacturer (see right column of Table 1 on of Appendix V). Enter the technical

parameters for the DCE‐MRI imaging protocol into the imaging series. Refer to the

parameters specified in the DCE‐MRI column in Table 1 of Appendix V of this manual.

Temporarily set the number of signal averages (NEX/NSA) to one and the flip angle to

30. Note specific vendor required settings in Table 4 of Appendix V. (GE users: use

Turbo=2 setting). Adjust parameters such as BW, phase matrix, FOV, and % phase FOV

within the allowed ranges from Table 1 of Appendix V to ensure that the time for the

sequence is between 5 and 8 seconds. You will need to reference this time later on

when creating the full protocol.

3. Save this sequence as “ACRIN6701_DCE_template_human” in the DCE_template folder.

This template will also be used to construct the human imaging sequence for the trial.

4. Make a copy of the “ACRIN6701_DCE_template_human” series and rename it as

“ACRIN6701_DCE_template_phantom”

5. Open “ACRIN6701_DCE_template_phantom” and make the following changes to this

sequence:

a. Change imaging plane to coronal

b. Set frequency direction to S/I and phase direction to R/L.

c. Set frequency and phase FOV to 360 each. Percent phase FOV should be 100%

d. Keep acquisition matrix unchanged, but set reconstruction matrix to 512 x 512

(Siemens users: check interpolate).

e. Remove parallel imaging.

f. Set number of slices to 26.

g. Change slice thickness to 4.25mm.



Preparing the QIBA DCE Phantom Imaging Protocol:

1. Open a new folder/protocol for “ACRIN6701_DCE_phantom.”

2. Add localizer sequences for body imaging as per institutional standard.

3. Copy the series labeled “ACRIN6701_DCE_template_phantom” and paste into the

phantom scanning protocol.

4. Open this series and make the following changes:

a. Set number of acquisitions/signal averages to 4

b. GE users: set Turbo=0

5. Rename this series as “ACRIN6701_Ph_VFA_flip_30.”

6. Copy this series and change flip angle to 25°. Siemens users: set acquisition properties

to “scan without further adjustment”.

7. Rename this series as “ACRIN6701_Ph_VFA_flip_25”.

8. Make five additional copies of this series. Successively open each one, changing flip

angle to 20°, 15°, 10°, 5°, 2° sequentially. Save each subsequent series as

“ACRIN6701_Ph_VFA_flipXXs” where “XX” is “20”, “15”, “10”, “05”, and “02”, for each

series.

9. Make a copy of the “ACRIN6701_Ph_VFA15_degree” series.

10. GE users: open this series and change to Turbo=2

11. Save/rename this series as “ACRIN6701_Ph_Ratio_map_Array_Coil”

12. Make a copy of the “ACRIN6701_Ratio_map_Array_Coil” series

13. Open this and change to Body coil acquisition. Siemens users: add comment to

technologist re coil change.

14. Save this series as “ACRIN6701_Ph_Ratio_map_Body_Coil”

15. Make a copy of the “ACRIN6701_Ph_VFA_30_degrees” series

16. Open this and make the following changes

a. Change number of signal averages to 1.

b. Change number of dynamic acquisitions based on previously noted time for the

“ACRIN6701_DCE_template_human” acquisition, as indicated below:

i. 5.0 ‐ 5.5 seconds 65 acquisitions

ii. 5.6 – 6.5 seconds 60 acquisitions

iii. 6.6 – 7.5 seconds 50 acquisitions

iv. 7.6 – 8.0 seconds 45 acquisitions

c. GE users: set Turbo=2 and MPH option

d. Siemens users: remove “scan without further adjustment” from acquisition

properties.

17. Save series as “ACRIN6701_Ph_Dynamic”.



This completes the phantom protocol set up. Your MRI‐DCE QIBA phantom protocol

should have the following series prepared, in the order shown:

localizer (recommend 3 plane

T1 Map 30° (tuned, with pre‐scan)

T1 Map 25° (not tuned, no pre‐scan)






Ratio map array coil

Ratio map body coil

Dynamic gadolinium (tuned, pre‐scan)

QIBA DCE Phantom Preparation Procedure:

1. Use the surface array coil per your institutional routine for pelvic imaging (i.e. torso‐

array)

2. Place the QIBA MRI‐DCE phantom in the center of the table, on top of the posterior

elements of the torso‐array coil

3. Add the anterior torso array coil elements to the top

4. Landmark to the center of the phantom.

Initiate localizer scanning. Once a satisfactory localizer imaging in the sagittal or axial

plane is obtained, prescribe the coronal slab from a central slice. Continue remaining

sequences, noting switch to body coil for the “Ratio_map_Body_Coil” series.

QIBA DCE Phantom Scan Procedure

T1 Mapping Series for DCE Body

1. Run the localizer scan to identify the phantom (may use either body coil or array coil

for image reception).

2. Open the T1 map flip 30°series. Switch to array coil for image reception.

3. Prescribe the 3D slab in the coronal plane through the center of the phantom,

centered in all 3 planes. Pre‐scan, as usual, for this series, then run.

4. Run the next T1 Map at 25°, copying the position of the 3D slab from the previous

series. DO NOT pre‐scan.

5. Run the next T1 Map at 20°, copying the position of the 3D slab from the previous

series. DO NOT pre‐scan.



6. Run the 15°, 10°, 5°, 2° T1 maps in the same manner as above without a pre‐scan.

Body Coil Ratio Map Series

1. Run the “Ratio_map_Array_Coil scan.

2. Run the “Ratio_map_Body_Coil scan. Make sure to switch to body coil as receive

coil. DO NOT run a pre‐scan.

Dynamic Series

1. Switch back to array coil as receive coil. Run the DYNAMIC SCAN, copying the

position of the 3D slab from the previous series. Pre‐ scan is allowed for this series.

ACRIN6701SiteImagingManual AppendixIII

MRIScan1:HumanImagingProceduresAppendixIII 09Oct2012Page1of11

Appendix III

MRI Scan 1

Human Imaging Procedures



MRI SCAN 1: Human Imaging Procedures Introduction

The following is a guideline document depicting the patient preparation and order of imaging for ACRIN 6701 MRI Scan 1. Note that this document is divided in to three sections:

1. Part I: Anatomic imaging procedures for sites not using an endo‐rectal coil (eCoil) (see page 3)

2. Part II: Anatomic imaging procedures for sites using an endo‐rectal coil (eCoil) (see page 5)

3. Part III: Non‐eCoil DWI and DCE‐MRI imaging (all sites see page 8) Sites should determine whether they will follow Part I or Part II of the anatomic imaging procedures, then all sites should proceed to Part III after completion of either Part I or Part II.



Part I:

Pre‐ DWI and DCE‐MRI Imaging Procedures

(For Institutions not Utilizing Endo‐rectal Coil (eCoil) for Anatomic Prostate Imaging)

Note: Institutions utilizing eCoil for anatomic imaging during MRI 1 should skip to Part II

Preparation

1. Document participant body weight on the MRI Scan Administration Form

2. Pre‐draw appropriate amount (0.1 mmol/kg) of protocol approved gadolinium and 20

mL normal saline into dual‐chamber power‐injector

3. Place intravenous line (20G or higher), preferably in right antecubital fossa, for

gadolinium contrast administration, then document injection site and catheter size on

the MRI Scan Administration Form

4. Place participant supine in MRI scanner; connect IV to power injector; and deploy

scanner‐specific local torso array coils about pelvic region

5. Landmark participant at the level of the symphysis pubis

Anatomic Image Acquisition

1. Perform pre‐contrast anatomic imaging as described below:

Note: Minimal required imaging is listed below, but any pre‐contrast imaging series per

institutional norms are permitted

a. Localizer: per institutional routine. It is strongly recommended that a large FOV

sagittal localizer is acquired for the planning of the DCE‐MRI acquisition. See Figures

1 & 2 on page 10 & 11 of this appendix for proper slab prescription.

b. High resolution T1‐weighted axial (or oblique axial) imaging:

Scanning should be tailored to the prostate, with the appropriate use of FOV

and image matrix values for high resolution prostate imaging.

Use institutional norms for type of T1 scanning and other acquisition

parameters.

Note: Oblique axial imaging (i.e perpendicular to the posterior edge of the

prostate) is acceptable if per institutional norms (see Figure 2, page 11). Use of

standard or oblique scanning planes should be uniform throughout examination.

c. High resolution T2‐weighted axial (or oblique axial) imaging:



Utilization of identical scan prescription (FOV, slice thickness, slice locations)

with that of T1 imaging is strongly encouraged.

Note acceptable parameter ranges in Table 1 of Appendix V

d. High resolution T2‐weighted coronal (or oblique coronal) imaging:

Utilization of oblique coronal imaging plane (i.e. parallel to the posterior

surface of the prostate is acceptable).

Utilize institutional norms for scanning parameters

2. Perform any additional standard of care pre‐gadolinium imaging per institutional norms.

Possible imaging series may include:

High resolution sagittal T2 imaging of the prostate

Large FOV T1 and/or T2 imaging to document nodal or osseous

metastatic disease

Supplemental DWI with eCoil (per institutional norms)

3. Please proceed to Appendix III‐Page 8 for the DWI and DCE‐MRI imaging instructions, at

the completion of the pre‐gadolinium imaging.



MRI SCAN 1: Imaging Procedures

Part II:

Pre‐DWI and DCE‐MRI Imaging Procedures

(For Institutions Utilizing Endo‐rectal Coil (eCoil) for Anatomic Prostate Imaging)

This portion of the imaging manual is for sites that choose to use eCoil for anatomic imaging of

the prostate. Sites should use this section for imaging if their institutional norms for clinical

exams of the prostate require the use of an eCoil at 3T imaging and the use of non eCoil exams

would result in imaging not deemed to be acceptable for clinical staging per institutional

standards. Note that even if an eCoil is normally utilized for anatomic and/or functional

prostate imaging at 3T, sites should consider whether non‐eCoil anatomic imaging may produce

clinically acceptable imaging, as this will improve patient throughput during this study. After

completion of MRI Scan 1, sites may review the imaging and determine whether eCoil imaging

for anatomic prostate evaluation may benefit the patient during MRI Scan 2.

Sites that choose to use eCoil imaging for anatomic prostate evaluation should first perform

eCoil‐based imaging, and then perform non‐eCoil DWI and DCE‐MRI study imaging.

Preparation







4. Deploy endo‐rectal coil

5. Place participant supine in MRI scanner; connect IV to power injector; and deploy

scanner‐specific local torso array coils about pelvic region


Anatomic Image Acquisition with eCoil

1. Perform pre‐contrast anatomic imaging as described below:

Note: Minimal required imaging is listed below, but any pre‐contrast imaging series per

institutional norms are permitted.

a. Localizer: per institutional routine

b. High resolution T1‐weighted axial (or oblique axial) imaging:



Scanning should be tailored to the prostate, with the appropriate use of FOV

and image matrix values for high resolution prostate imaging.

Use institutional norms for type of T1 scanning and other acquisition

parameters.

Note: Oblique axial imaging (i.e perpendicular to the posterior edge of the

prostate) is acceptable if per institutional norms (see Figure 2, page 11). Use of

standard or oblique scanning planes should be uniform throughout examination.

c. High resolution T2‐weighted axial (or oblique axial) imaging:

Utilization of identical scan prescription (FOV, slice thickness, slice locations)

with that of T1 imaging is strongly encouraged.

Note acceptable parameter ranges in Table 1 of Appendix V

d. High resolution T2‐weighted coronal (or oblique coronal) imaging:

Utilization of oblique coronal imaging plane (i.e. parallel to the posterior

surface of the prostate is acceptable.

Utilize institutional norms for scanning parameters

2. Perform any additional standard of care pre‐gadolinium imaging per institutional

norms.

Possible imaging series may include:

High resolution sagittal T2 imaging of the prostate

Large FOV T1 and/or T2 imaging to document nodal or osseous

metastatic disease

Supplemental DWI with eCoil (per institutional norms)

Note: DWI performed with eCoil is at the discretion of the imaging site PI. Scanning parameters

for eCoil DWI series should be based on institutional norms and need not utilize study‐specific

DWI parameters.

Note that DWI imaging without eCoil, per study guidelines, must be performed even if eCoil DWI

imaging is utilized.

3. Prepare for Non‐eCoil Anatomic Imaging

Remove endo‐rectal coil from patient.

Re‐place participant supine in MRI scanner; connect IV to power injector; and re‐

deploy scanner‐specific local torso array coils about pelvic region



Landmark participant at the level of the symphysis pubis

Non‐eCoil Anatomic Image Acquisition

1. Localizer: per institutional routine. It is strongly recommended that a large FOV sagittal

localizer is acquired for planning the DCE MRI acquisition. See Figures 1 & 2 on pages 10

& 11 of this appendix.

2. T2‐weighted axial (or oblique axial) imaging

The utilization of oblique imaging planes is permitted (see Figure 2, page 11), but

should be used uniformly throughout all portions of this section.

Imaging should be sufficient to localize prostate for comparison with DWI and

DCE‐MRI imaging. High resolution imaging is not required at this stage. Rapid T2

FSE imaging, such as SS‐FSE, HASTE, etc; is acceptable.

3. Please proceed to Appendix III‐Page 8 for the DWI and DCE‐MRI imaging instructions,

at the completion of the pre‐gadolinium imaging.




Part III:

DWI and DCE‐MRI Imaging Procedures

(Non‐eCoil‐ All sites)

The following guidelines are for study‐required non‐eCoil DWI and DCE‐MRI imaging. These

instructions should be followed by each imaging center after completion of either Part I or Part

II of these instructions.

DWI/DCE Image Acquisition Procedures

1. Perform Multi‐B value axial (or oblique axial) SE‐EPI DWI (with B values of 0, 100, 600,

and 800 s/mm2))

The utilization of oblique imaging planes are permitted (see Figure 2, page 11),

but should be used uniformly throughout all portions of this section.

See Table 1 in Appendix V for detailed imaging instructions

Certain scanner systems may not allow the use to run more than one non‐zero B‐

value during DWI. If Multi‐B value DWI imaging is not permitted on your MRI

system, this section should be run in three distinct series.

Label series accordingly:

o Series 1: B values 0 & 100



2. Prescribe axial (or oblique axial) 3D volume for DCE‐MRI study:



Axial volume of 32 x 5mm slices must be prescribed; do not center imaging over

the prostate. Rather, the prostate should be at the lower portion of the imaging

volume to minimize vascular in flow affects. See Figures 1 & 2 on Pages 10 & 11

of this appendix for details regarding slab placement. Perform all series using

same exam prescription.

Do not perform pre‐scan/preparation between series; unless indicated

otherwise

See Table 1 of Appendix V for detailed imaging information.

3. DCE‐MRI Imaging Series:



Multi‐flip‐angle T1 mapping protocol (30° , 25°, 20°, 15°, 10°, 5°, 2°)

Array Body coil only imaging for receive coil bias field calculation

Dynamic Enhanced Imaging

Note on SAR:

In the event of a SAR error the technologist should only make adjustments to the flip angle;

please do not make any additional parameter adjustments.

If, on a subject’s initial scan, a SAR error requires dynamic enhanced imaging to be run at a flip

angle less than 30° the flip angle adjustment should be noted and this parameter should be

replicated, if possible, at all subsequent visits.

4. Contrast Administration for DCE Imaging

The gadolinium agents MultiHance, Eovist, and Vasovist are NOT permitted for

this study

The same brand and dose of contrast, same IV site, and same rate of contrast

and saline flush administration should be maintained for both the test and re‐

test examinations.

Contrast agent should be administered in a dynamic fashion beginning 30‐40

seconds after the start of the dynamic enhanced imaging.

Contrast agent should be administered at a dose of 0.1 mmol/kg body weight

and rate of 2 mL/second, followed by a 20 mL saline flush, also at 2 mL/second.

Document the amount of contrast administered on the MRI Scan Administration

Form

5. Post gadolinium imaging, per institutional norms, may be performed after completion

of the dynamic enhanced imaging series.


MRIScan1:HumanImagingProceduresAppendixIII09Oct2012 Page10of11

Figure 1: DCE MRI Slab Prescription for Axial Imaging

Scout View Correct Slab Placement (Circle=Prostate C=eCoil)

Incorrect (Slab too thin) Incorrect (Slab set too low)


MRIScan1:HumanImagingProceduresAppendixIII09Oct2012 Page11of11

Figure 2: DCE MRI Slab Prescription for Oblique Axial Imaging

ScoutView CorrectSlabPlacement(Circle=ProstateC=eCoil)


ACRIN6701SiteImagingManual AppendixIV

MRIScan2:HumanImagingProceduresAppendixIV 09Oct2012Page1of7

Appendix IV

MRI Scan 2

Human Imaging Procedures




The following guidelines are for study‐required non‐eCoil DWI and DCE‐MRI imaging for ACRIN

6701 MRI Scan 2. Note that MRI Scan 2 is not for clinical use unless deemed necessary by the

local site radiology PI. In such cases, the local site radiology PI should indicate to the MRI

technologist prior to the examination which additional imaging should be performed.

Specifically, endo‐rectal coil (eCoil) imaging should not be performed at this time unless

explicitly indicated by the site PI to repeat non diagnostic anatomic imaging series obtained at

the time of MRI Scan 1.

Note: this MRI scan visit includes a “coffee break” where the technologist will be required to

briefly remove the participant from the scan table.

Preparation







4. Place participant supine in MRI scanner; and deploy scanner‐specific local torso array

coils about pelvic region. Do not connect the participant to the power injector at this

time.


Non‐eCoil Anatomic Image Acquisition

1. Localizer: per institutional routine.

2. T2‐weighted axial (or oblique axial) imaging



Imaging should be sufficient to localize prostate for comparison with DWI and

DCE‐MRI imaging. High resolution imaging is not required at this stage. Rapid T2

FSE imaging, such as SS‐FSE, HASTE, etc; is acceptable.

3. Additional pre‐gadolinium anatomic imaging series for clinical care (if required) may be



performed at this time.

DWI/DCE MRI Image Acquisition Procedures

1. Perform “Pre‐Coffee Break” Multi‐B value axial (or oblique axial) SE‐EPI DWI (with B

values of 0, 100, 600, and 800 s/mm2))

The utilization of oblique imaging planes is permitted, but should be used

uniformly throughout all portions of this section.

See Table 1of Appendix V for detailed imaging instructions

Certain scanner systems may not allow the user to run more than one non‐zero

B‐value during DWI. If Multi‐B value DWI imaging is not permitted on your MRI






2. Implement a “Coffee Break”

Remove the participant from the MRI table for approximately 1‐2 minutes

Place participant supine on the MRI table

Connect IV to power injector; and deploy scanner‐specific local torso array coils about pelvic region

Landmarked at the level of the symphysis pubis.

3. Imaging Prior to Post “Coffee Break” DWI Series

Localizer: per institutional routine. It is strongly recommended that a large FOV

sagittal localizer is acquired for planning the DCE MRI acquisition (see Figure 2,

page 7).

T2‐weighted axial (or oblique axial) imaging

o The utilization of oblique imaging planes is permitted (see Figure 2, page 7),

but should be used uniformly throughout all portions of this section.

o Imaging should be sufficient to localize prostate for comparison with DWI

and DCE‐MRI imaging. High resolution imaging is not required at this stage.

Rapid T2 FSE imaging, such as SS‐FSE, HASTE, etc; is acceptable.

4. Perform “Post‐Coffee Break” Multi‐B value axial (or oblique axial) SE‐EPI DWI (with B



values of 0, 100, 600, and 800 s/mm2))

The utilization of oblique imaging planes is permitted, but should be used

uniformly throughout all portions of this section.

See Table 1 in Appendix V for detailed imaging instructions

Certain scanner systems may not allow the user to run more than one non‐zero

B‐value during DWI. If Multi‐B value DWI imaging is not permitted on your MRI






5. Prescribe axial (or oblique axial) 3D volume for DCE‐MRI study:



Axial volume of 32 x 5mm slices must be prescribed; do not center imaging over

the prostate. Rather, the prostate should be at the lower portion of the imaging

volume to minimize vascular in flow affects. See Figures 1 & 2 on Pages 6 & 7 of

this appendix for details regarding slab placement. Perform all series using same

exam prescription.

Do not perform pre‐scan/preparation between series; unless otherwise

indicated

See tables in Appendix V for detailed imaging information.

6. DCE‐MRI Imaging Series:

Multi‐flip‐angle T1 mapping protocol (30° , 25°, 20°, 15°, 10°, 5°, 2°)

Array Body coil only imaging for receive coil bias field calculation

Dynamic Enhanced Imaging

Note on SAR:

In the event of a SAR error the technologist should only make adjustments to the flip angle;

please do not make any additional parameter adjustments.

If, on a subject’s initial scan, a SAR error requires dynamic enhanced imaging to be run at a flip

angle less than 30° the flip angle adjustment should be noted, and this parameter should be

replicated, if possible, at all subsequent visits.



7. Contrast Administration for DCE Imaging

The gadolinium agents MultiHance, Eovist, and Vasovist are NOT permitted for

this study

The same brand and dose of contrast, same IV site, and same rate of contrast

and saline flush administration should be maintained for both the test and re‐

test examinations.

Contrast agent should be administered in a dynamic fashion beginning 30‐40

seconds after the start of the dynamic enhanced imaging.

Contrast agent should be administered at a dose of 0.1 mmol/kg body weight

and rate of 2 mL/second, followed by a 20 mL saline flush, also at 2 mL/second.

Document the amount of contrast administered on the MRI Scan Administration

Form

8. Post gadolinium imaging, per institutional norms, may be performed after completion

of the dynamic enhanced imaging series.


MRIScan2:HumanImagingProceduresAppendixIV09Oct2012 Page6of7

Figure 1: DCE MRI Slab Prescription for Axial Imaging

Scout View Correct Slab Placement (Circle=Prostate C=eCoil)



MRIScan2:HumanImagingProceduresAppendixIV09Oct2012 Page7of7

Figure 2: DCE MRI Slab Prescription for Oblique Axial Imaging

ScoutView CorrectSlabPlacement(Circle=ProstateC=eCoil)


ACRIN6701SiteImagingManual AppendixV

ImageAcquisitionParametersAppendixV 09Oct2012Page1of7

Appendix V

Image Acquisition

Parameters



ACRIN 6701 MRI Image Acquisition Parameters

This appendix provides detailed instructions regarding key imaging parameters for the

experimental imaging series in the protocol. The first table represents the parameter setting

required for T2‐weighted imaging, diffusion weighted imaging, and DCE‐MRI. Where applicable,

vendor‐specific nomenclature is provided in the table. For DCE‐MRI, the first table highlights

the general acquisition parameters for setting the volumetric imaging slab. Details specific to

each of the three sub‐portions of the DCE‐MRI protocol (variable flip angle [VFA] mapping, body

coil ratio map acquisition, and dynamic enhanced imaging) are provided in the second section

of this appendix.



Table 1: Key Acquisition Parameters for T2‐weighted, DWI, and DCE‐MRI

Parameter T2‐weighted

(non eCoil) *(1) T2‐weighted

(with eCoil) *(1) DWI DCE‐MRI *(2)

Sequence type FSE/TSE FSE/TSE DW SE‐EPI Spoiled GRE S *(3): Fl3d_vibe

P *(3): FFE G *(3): 3D FSPGR

2D or 3D sequence 2D 2D 2D 3D

Slice orientation Axial *(4) Axial *(4) Axial *(4) Axial *(4)

Frequency direction A/P A/P R/L R/L

Phase direction L/R L/R A/P A/P

FOV – frequency 180‐260 mm 120‐180 mm 320‐400 mm *(5) 320‐400 mm *(5)

FOV ‐ phase 180‐260 mm 120‐180 mm 260‐320 mm*(5) 260‐320 mm *(5)

Partial FOV 100% 100% 75‐85% *(5) 75‐85% *(5)

Phase oversampling As needed As needed No No

Matrix – frequency (acquired) 256‐512 256‐512 128‐192 256

Matrix – phase (acquired) 160‐384 160‐384 128‐192 128‐192

Reconstruction Matrix 512 x 512 512 x 512 256 x 256 256 x 256

Parallel Imaging Factor Per routine Per routine 2x 2x

Fat‐suppression None None Yes *(6) None

Spatial Saturation Per routine Per routine None None

TR 3000‐10000 ms 3000‐10000 ms > 4,000 ms 3‐10 ms *(7)

TE 70‐140 ms 70‐140 ms <=90 ms < 3 ms *(7)

Echo Train Length Per routine Per routine N/A N/A

Flip Angle 90‐180 degrees 90‐180 degrees 90 degrees see next section



(*) Parameter Notes:

1. Axial (or oblique axial) T1 and coronal (or oblique coronal T2) parameters are not specified. These may be performed per

institutional routines. It is recommended that the slice prescription for T1 (oblique) axial series follow that of T2 (oblique) axial

imaging. (Oblique) coronal T2 imaging should be run with a parameter set similar to that of the (oblique) axial T2 data set.

2. Includes geometric and general acquisition parameters for each of the three components of the DCE‐MRI portion of the study.

Use these settings for all aspects of the DCE‐MRI acquisition. See second section on page 7 for details specific to each portion

(VFA mapping, coil ratio mapping, and dynamic enhanced imaging.)

3. Vendor‐specific notation: S = Siemens, P = Philips, G= GE.

4. May use oblique axial (parallel to posterior edge of prostate). Use of oblique axial plane should be consistent throughout all

imaging series.

5. Ensure that entire AP width of pelvis is included to avoid parallel imaging artifacts. Recommend increased frequency FOV as

needed such that at least 85% rectangular phase FOV reduction is achievable without phase wrap.

6. Use either Short T1 Inversion Recovery (STIR) or Spectral Adiabatic Inversion Recovery (SPAIR) fat suppression.

7. Use minimum TR and TE achievable based on other settings, but TR should be no less than 3 ms.

8. It is preferred to acquire all four b‐values in a single series. If your system cannot collect multiple b‐values in a single “pass”,

then three separate series should be acquired and named as follows: “DWI_b100”: b=0 & 100; “DWI_b600”: b=0 & 600;

“DWI_b800”: b=0 & 800. Do NOT allow TE to change (e.g., set “OPTIMIZE TE” to “NO”), and do not allow the system to adjust

hardware settings (e.g., transmit/receive gain) between DWI series. See instructions in Appendix 1 for more details.

Parameter T2‐weighted1 (non eCoil)

T2‐weighted1 (with eCoil)

DWI DCE‐MRI2

Readout BW [S/P: (Hz/Px) G: (kHz)] Per routine Per routine S/P: 1500‐2500 G: ±128 kHz or “maximum”

S/P: 400‐600 G: ±50 ‐ ±100 kHz

b‐values (s/mm2) N/A N/A 0, 100, 600, 800 *(8) N/A

Slice thickness (acquired) 2.5‐4 mm 3‐5 mm 5 mm 5 mm

Number of slices Variable Variable Variable 32

Slice gap mm mm 0 N/A

No. of excitations or averages Per routine Per routine 3‐6 see next section

Sequence acquisition time Per routine Per routine 7minutes see next section



Table 2: Vendor‐Neutral Acquisition Parameters for DCE‐MRI

Vendor‐Neutral Settings Variable Flip Angle Mapping Body Coil Ratio Map Dynamic Enhanced Imaging

Coil Torso array Part 1: Body coil Part 2: Torso array

Torso array

Number of separate series 7 2 1

Number of dynamic acquisitions (“phases”)

N/A N/A 40‐60 *(1)

Pre‐scan prior to acquisition(s) For first flip angle only Yes Yes

Save scan(s) as Separate series Separate series Single series *(2)

Name series as “VFA_flip_XX” Part1: “Ratio map body” Part 2: “Ratio map torso”

“Dynamic_Gad”

Flip angle(s) 2, 5, 10, 15, 20, 25, 30 15 30

Acquisitions/NEX 4 4 1

Time per acquisition 20‐40 seconds 20‐40 seconds 5‐8 seconds *(1)

Total time 2‐5 minutes 1.0‐1.5 minutes 4‐7 minutes *(1)

Contrast (saline) amount N/A N/A 0.1 mmol/kg (max. 20 mL)

Injection rate N/A N/A 2 mL/second

Start injection time N/A N/A 15‐20s after scan initiation



DCE‐MRI Notes:

1. Dynamic scan time must fall between 5 and 8 seconds. Minimum number of phases of dynamic scan should be 45, which

corresponds to a maximum total scan time of approximately 6minutes for a per phase temporal resolution of 8 seconds. For

shorter temporal resolutions, scan time should be between 5‐6 minutes. Recommended settings are as follows:

Dynamic Temporal Resolution Total Number of Phases Total Scan Time

7.6‐8 seconds 45 5:25‐6:00

6.6‐7.5 seconds 50 5:30‐6:15

5.6‐6.5 seconds 60 5:36‐6:30

5.0‐5.5 seconds 65 5:25‐5:58

Table 3:



Table 4: Vendor‐Specific Acquisition Parameters for DCE‐MRI

Please ensure that the correct vendor‐specific settings are employed as described below:

Vendor‐specific settings Variable Flip Angle Mapping Body Coil Ratio Map Dynamic Enhanced Imaging

GE

User CV/Advanced Turbo=0 Turbo=2 Turbo=2

User CV/Advanced Slice Resolution = 100% Slice Resolution = 100% Slice Resolution = 100%

Imaging options EDR EDR EDR, MPH

SCIC / PURE Off Off Off

Philips

CLEAR Off Off Off

Partial Echo Off Off Off

Shifted Echo Off Off Off

Half Scan Yes Yes Yes

Factor Y 0.65 0.65 0.65

Factor X 0.85 0.85 0.85

Siemens

Partial Fourier – phase Off Off Off

Partial Fourier ‐ slice Off Off Off

Phase Resolution 60%‐70% 60%‐70% 60%‐70%

Slice resolution 60%‐70% 60%‐70% 60%‐70%

Normalize Off Off Off

Elliptic/Centric Scanning Off Off Off

RF Pulse Type Normal Normal Normal

Gradient Mode Fast Fast Fast

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