SWOG S0438 / ACRIN 6675: Positron Emission Tomography (PET)
American College of Radiology Imaging Network
Protocol Specific Application
Section I: Site Information
Name of Institution:
City:
State:
Zip Code:
Section II: Site Status
1. Your institution must be a current SWOG or ECOG member or affiliated with a member of SWOG or
ECOG:
□ SWOG assigned institution #
□ ECOG assigned institution #
_______
_______
□ NCI institution #
□ NCI institution #
2. Please provide your institution’s current Office for Human Research Protections (OHRP) approved
assurance type and number:
Type (MPA/FWA)
Assurance Number:
Section III: Personnel Information
Personnel Responsible for the Imaging Component (ACRIN) Data:
1. Investigator Responsible for the PET Imaging (ACRIN PI) (Board Certified Nuclear Medicine Radiologist)
(Attach CV)
Name:
Address:
Address:
City, State, Zip code:
Telephone Number:
Fax Number:
E-mail Address:
2. Research Associate who will Obtain PET Data (ACRIN RA)
Name:
Address:
Address:
City, State, Zip code:
Telephone Number:
Fax Number:
E-mail Address:
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SWOG S0438 / ACRIN 6675: Positron Emission Tomography (PET)
American College of Radiology Imaging Network
Protocol Specific Application
SWOG or ECOG Personnel:
1. SWOG or ECOG Principal Investigator for the Institution
Name:
Address:
Address:
City, State, Zip code:
Telephone Number:
Fax Number:
E-mail Address:
2. SWOG or ECOG Head Clinical Research Associate for the Institution
Name:
Address:
Address:
City, State, Zip code:
Telephone Number:
Fax Number:
E-mail Address:
Section IV: Imaging Equipment
A full-ring PET scan unit or a PET/CT scanner is required for participation in the protocol. (Please note:
Detector material should be BGO, GSO, and LSO only. Sodium Iodide Nal instruments will not be eligible in this study)
1. The following is required to perform PET imaging in the SWOG S0438/ACRIN 6675 protocol:
Your PET scanner must have the following capabilities, (please place a check once all requirements are
confirmed at your site):
□ Perform both emission and transmission images (CT-based attenuation-correction is acceptable)
□ A field of view appropriate for body imaging (>10cm)
□ High resolution (FWHM <6.0mm) and high sensitivity
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SWOG S0438 / ACRIN 6675: Positron Emission Tomography (PET)
American College of Radiology Imaging Network
Protocol Specific Application
2. Is your institution able to perform all PET imaging criteria as described in Section 7.5 and Appendix
19.8 of the protocol document?
□Yes
□No
If no, comment:
3. Will your institution perform diagnostic-quality CT scans (as described in Sections 7.5 and 10.1) as
part of a combined PET/CT study, or will the PET and correlative CT/MRI studies be obtained
separately?
□Combined PET/CT
□Separate PET and CT /MRI
4. Please confirm the information on the PET imaging equipment for the trial.
Manufacturer
Model
Is the scanner ACR
accredited?
See note.1
Yes
No
Yes
No
Yes
No
Accreditation
expiration date(s)
1
If the site does not have ACR PET accreditation, a PET QA Questionnaire (Attachment I)
must be submitted with the PSA..
5. ACRIN 6675 Qualification of the PET imaging equipment for the trial.
Please Note: This trial specific qualification is required prior to registering a patient or completing the
baseline PET scan on a patient registered to the trial. PET qualification is required in addition to the ACR
PET accreditation / PET QA Questionnaire listed in part 4 above.
The PET qualification application and instructions are located on the ACRIN website:
http://www.acrin.org/6675protocol.html
Institutions that have received PET approval for other ACRIN studies may be eligible for expedited
qualification after discussion with the ACRIN imaging support staff. To determine if your site is already
PET qualified or for additional information on PET qualification, please contact Anthony Levering, ACRIN
Imaging Specialist (Ph: 215-574-3244; alevering@phila.acr.org). Notification of PET qualification
approval will be sent to the site personnel listed on this application via email.
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SWOG S0438 / ACRIN 6675: Positron Emission Tomography (PET)
American College of Radiology Imaging Network
Protocol Specific Application
Section V: Information Systems Technology
Each participating site is required to submit the PET and Correlative CT/MRI images to ACRIN as study data.
It is possible to send these images either electronically via an ftp site or on a CD. Plain/hard copy films will not
be accepted.
ACRIN can provide software to allow collection and submission of the image sets from the various modalities
or your PACS. The images are “DICOM pushed” to the PC that the provided software is installed on either
from the modality (MRI, PET, CT etc.) or from the PACS. The software ACRIN provides anonymizes,
encrypts, and non-destructively compresses the images as they are transferred by ftp to the ACRIN database in
Philadelphia.
If you would prefer to use the software to transfer images to ACRIN, please review the following computer
requirements for the image transfer process and confirm compliance with the requirements:
 Operating System Windows 2000 Pro or XP Pro.
 Access to the Internet: Internet Explorer 6.0 or Netscape 6.0 higher browser
 Minimum of 50 GB available hard drive.
 512 MB RAM
 Ability to view pdf documents
If you have a computer that is compatible for electronic image transfer as noted above and you would like to utilize
the software, please check yes and provide the name, phone and email of the person that ACRIN should contact:
□Yes,
Name:
Phone:
Email:
Section VI: Signatures
SWOG or ECOG Principal Investigator for the Institution:
Signature:
Date:
Investigator Responsible for the PET Imaging (ACRIN PI):
Signature:
Date:
Forward your application to: American College of Radiology
ACRIN Administration – 6675 Protocol Manager
1818 Market Street, Suite 1600
Philadelphia, PA 19103
Fax:
215-717-0936
If you email your application (dhartfeil@phila.acr.org), please fax or send via mail the last page with
the signature and date of the Protocol Investigators.
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Attachment I
ACRIN PET Quality Assurance Program Questionnaire
The following information is required for sites applying to participate in ACRIN trials involving
PET imaging that do not have ACR or ICANL accreditation.
Nuclear Medicine Physicians Qualifications
Number of nuclear medicine physicians who interpret PET studies:
Number of above physicians who are board certified* in diagnostic radiology, nuclear radiology, or
nuclear medicine
*Certification may be by the American Board of Radiology, American Board of Nuclear Medicine,
American Osteopathic Board of Radiology, American Osteopathic Board of Nuclear Medicine, Royal
College of Physicians and Surgeons of Canada, or Le College des Medicins du Quebec.
Do all physicians who interpret PET studies participate in 15 or more CME hours in PET over a threeyear time period?
yes
no
Please record the number of PET cases performed at the site in the last calendar year
Technologists
Number of full-time registered technologists who perform PET studies
 Number of above technologists who are nuclear medicine registered or certified (ARRT(N),
CNMT, CAMRT(RTNM) or CAMRT)
o
Number of above technologists who have PET certification.
Physicist
Identify the medical physicist who reviews the quality control program and equipment performance at
your facility
Submit his or her CV with the questionnaire.
Is the medical physicist certified in medical nuclear physics or radiologic physics?
yes
no
Does the PET facility’s medical physicist have 40 or more hours of on-site practical
experience providing physics support?
yes
no
Physician Peer-Review
Is a physician peer review program in place?
yes
no
If yes, briefly describe
Name and Title of the Person completing this QA Questionnaire:
Signature:
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