ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
Please Note: This PSA should be completed by sites that have previously participated in
RTOG 0625/ACRIN 6677.
Please submit in electronic format.
Contact 6686 protocol manager Bernadine Dunning (Ph: 215-574-3228 and/or E: bdunning@acr-arrs.org)
for more information.
Name of Site:
Address:
Study Team
MRI Physician/Radiologist (Attach CV):
Address:
Telephone:
Fax:
E-mail:
ACRIN Research Associate/Coordinator:
Address:
Telephone:
Fax:
E-mail:
Fax:
E-mail:
Lead MRI Technologist:
Address:
Telephone:
MRI Technologist (Tech. responsible for the acquisition of the scans:
Address:
Telephone:
Fax:
E-mail:
Fax:
E-mail:
MR Physicist:
Address:
Telephone:
Primary Supporting Oncologist:
Address:
Telephone:
Version Date: 10/6/2009 R1
Fax:
E-mail:
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ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
Oncology RN/Coordinator:
Address:
Telephone:
Fax:
E-mail:
Information Systems Technology
Sites are required to submit MRI images in DICOM format to the ACRIN core laboratory. Sites are
encouraged to transfer images using TRIAD software, provided by ACRIN for installation on a
site’s PC. TRIAD collects image sets from a scanner’s computer or from the picture archiving
communications system (PACS). TRIAD anonymizes, encrypts, and non-destructively compresses
the images as they are transferred to the ACRIN image archive in Philadelphia. Sites may also use a
secured file transfer protocol (sFTP) to submit images to a specified location on the ACRIN server;
or they may submit images on a CD to the ACRIN Imaging Core Laboratory. Plain/hard copy films
are not accepted.
Will your site grant the necessary firewall permissions to transfer
electronic image files from a TRIAD server at your site to ACRIN’s
image archive via the Internet?
Please indicate if your site has a PC available with the following
specifications to support the TRIAD software:
 Operating System Windows XP Pro, Windows 2000 Server SP4
and above, and Windows 2003 server
 Intel P-III 1 GHz minimum processor
 Access to the Internet: Internet Explorer
 A 100 GB hard drive is preferred
 At least 512 MB RAM
 Ability to view PDF documents
 Software utilities required to run image transmission software:
o Windows Installer 3.1
o Microsoft .NET framework 2.0
o MDAC Type 2.8
o MS SQL 2005 Express
Yes
No
Yes
No
Please contact the ACRIN TRIAD help desk to arrange for installation of TRIAD software prior to
first accrual at Triad-Support@acr-arrs.org or by phone at 215-940-8820.
Version Date: 10/6/2009 R1
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ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
Imaging Equipment
MRI Scanner Information:
Please provide the following information for all MRI scanners to be used this study.
Manufacturer
Model/ Magnet
Strength
Is the scanner ACR
accredited?
See note.
Yes
No
Yes
No
Yes
No
Accreditation expiration
date(s)
Note: If the site does not have American College of Radiology (ACR) MR accreditation, an
MR QA Questionnaire must be submitted with the PSA. The MR QA questionnaire can be
found at www.acrin.org/6686_protocol.aspx and is also included on page 8 of this application.
Is your site able to perform the MRI scan acquisition parameters described in
Appendix XIII of the protocol?
Yes
No
MRI Scanner Qualification
ACRIN qualification of the MRI scanner to be used on this study is also required prior to
enrollment of study participants. This is separate from the ACR accreditation requirement
noted above.
A test imaging submission consisting of all required advanced imaging series, performed
per protocol specifications must be submitted for scanner qualification for advanced
imaging.
Instructions for scanner qualification for ACRIN 6686 are available on the protocol-specific Web
page (click on the “Imaging Materials” section) at www.acrin.org/6686_protocol.aspx or contact
Jim Gimpel RT(R) (MR) at jgimpel@acr-arrs.org or 215-574-3238 for parameters and imaging
instructions.
Version Date: 10/6/2009 R1
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ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
ACRIN Protocol Principal Investigator Confirmation
I,
(Name of Protocol Principal Investigator*) have reviewed and agree with the information
contained in this application.
Signature (electronic signature is acceptable):
Date:
E-mail:
Application Submission Information:
Please e-mail the completed application to: acrin_application@phila.acr.org. (Preferred delivery)
To mail or fax the application and materials:
American College of Radiology
Attn: ACRIN 6686 PSA
Diagnostic Administration
1818 Market Street, Suite 1600
Philadelphia, PA. 19103-3604
Fax: 215-717-0936
Version Date: 10/6/2009 R1
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ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
MRI Quality Assurance Program Questionnaire
The following information is required for sites applying to participate in ACRIN 6686 that do not have
ACR MRI accreditation.
Technologist Qualifications



Number of full-time technologists performing MRI scans:
Number of above technologists who are registered:
Number of above registered technologists with MRI certification:
Radiologist Qualifications

Number of board certified radiologists who interpret MRI scans:
o Number of above radiologists who have at least 150 hours of CME over a three-year period:



Type of MRI related certifications or fellowships held by facility radiologists
Hours an MRI supervising radiologist is available in the MRI department daily:
Number of MRI body and musculoskeletal cases interpreted for the most recent calendar year:
o
o


Does the facility or department have dedicated readers for body and musculoskeletal cases?
Yes
No
If yes, how many?
Number of MRI neuro cases interpreted for the most recent calendar year:
o Does the facility or department have a dedicated neuro reader?
Yes
No
o If yes, how many?
Please list any other MRI sub-specialties for which the department has dedicated readers:
Medical Physicist

Identify medical physicist who oversees the quality control program and attach CV:

Is medical physicist certified by the American Board of Radiology in the following sub-fields?
Diagnostic Radiological Physics
Yes
No
Radiological Physics
Yes
No
Quality Assurance Program

Does your institution have a Quality Assurance program in place that outlines policies and
procedures related to quality, patient education, infection control, and safety?
Yes (attach copy if applicable)
No

Does your facility maintain documentation on site of any results of an appropriateness/outcomes
analysis and actions taken to correct any deficiencies?
Yes
No
Version Date: 10/6/2009 R1
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ACRIN 6686 Protocol-Specific Application
ACRIN 6686/ RTOG 0825: A phase III double blind placebo controlled trial of conventional
chemoradiation and adjuvant temozolomide plus bevacizumab vs. conventional concurrent
chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma.
MR Equipment Quality Control
Does all equipment meet state and federal requirements?
Yes
No
Does facility have regularly scheduled preventive maintenance checks performed and documented by a
qualified service engineer on a regular basis?
Yes
No
Does facility site maintain documentation of services performed to correct any system deficiencies?
No
Yes
Please complete the following regarding MR equipment performance checks:
Checked Annually by Medical Physicist?
No
Yes
(If no, provide frequency of inspection)
Magnetic Field Homogeneity
Slice Position Accuracy
Slice Thickness Accuracy
Radiofrequency Coil Checks
Inter-Slice Radiofrequency Interference
Soft-Copy Displays (Monitors)
Checked Weekly by Technologist?
No
Yes
(If no, provide frequency of inspection)
Center frequency
Table Positioning
Setup and Scanning
Geometric Accuracy
High-Contrast Resolution
Low-Contrast Resolution
Artifact Analysis
Film Quality Control
Visual Checklist
Publications

Attach a list of recent MRI related publications, if any, authored by radiologists who interpret MRI
cases.
Name and title of individual completing this questionnaire:
Date:
Version Date: 10/6/2009 R1
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