ACRIN 6687 Protocol-Specific Application
PHASE II TRIAL OF 18F-FLUORIDE PET AS A
PHARMACODYNAMIC BIOMARKER
Introduction
The ACRIN 6687 protocol is a companion imaging protocol to accompany the therapeutic protocol (Duke
Genomic Trial) designed by Dr. Phillip G. Febbo of Duke University. We are approaching centers that are
participating in Dr. Febbo’s protocol, entitled “Genomic Guided Therapy with Dasatinib or Nilutamide in
Metastatic Castration-Resistant Prostate Cancer,” for interest in this companion imaging protocol.
Our companion imaging protocol, entitled “A Phase 2, Multicenter, Evaluation of 18F-fluoride PET as a
Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant
Prostate Cancer and Bone Metastases,” will allow eligible patients currently enrolled in Dr. Febbo’s
therapeutic trial and receiving dasatinib to undergo 18F-fluoride PET imaging. This includes patients
randomized initially to dasatinib alone, as well as those patients who may crossover at the time of
progression to have dasatinib added to nilutamide. Patients receiving nilutamide alone will not be eligible
for our companion imaging protocol.
The specific objective for the ACRIN companion imaging trial is to determine whether changes in regional
fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), will occur in both castration-resistant
prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.
A total of twenty-four (24) patients with castration-resistant prostate cancer bone metastases, currently
enrolled in Dr. Febbo’s trial, will be enrolled in this companion imaging biomarker study. It is anticipated
that accrual will be completed in 1.5 years with minimum of sixteen (16) patients enrolled in a year.
Application for Participation
The following is a protocol specific application (PSA) for the companion imaging protocol. Based on the
imaging requirements for this companion study, a PSA and qualification of the PET/CT scanner to be
used on the trial are required prior to enrollment.
The PSA is attached and should be completed and returned to ACRIN for review and approval.
Information on PET/CT scanner qualification through ACRIN is included in the PSA. Many centers have
already participated in ACRIN trials and may have PET/CT scanner approval already.
Please contact Donna Hartfeil at ACRIN for all questions related to this application and trial material
information:
Donna Hartfeil
ACRIN Project Manager
Phone: 215-717-2765
Email: dhartfeil@acr-arrs.org
ACRIN 6687 (v.4_12.28.09)
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ACRIN 6687 Protocol-Specific Application
PHASE II TRIAL OF 18F-FLUORIDE PET AS A
PHARMACODYNAMIC BIOMARKER
Please complete the Protocol-Specific Application in electronic format. This will expedite the
processing of the application and help maintain correct information on file.
Contact ACRIN 6687 Project Manager Donna Hartfeil at 215-717-2765 or dhartfeil@phila.acr.org should
you have any questions.
A. Study Team
Name of Site:
Nuclear Medicine Physician/Radiologist:
Address:
Telephone:
Fax:
E-mail:
Primary Oncologist for Dr. Febbo’s Clinical Trial:
Address:
Telephone:

Fax:
E-mail:
Of the physicians listed above, who will serve as the protocol principal investigator?
(Please submit the CV of both investigators listed above with this application.)
ACRIN Research Associate/Companion Imaging Protocol Coordinator:
Address:
Telephone:
Fax:
E-mail:
Oncology RN/Coordinator:
Address:
Telephone:
Fax:
E-mail:
Lead PET Technologist:
Address:
Telephone:
ACRIN 6687 (v.4_12.28.09)
Fax:
E-mail:
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ACRIN 6687 Protocol-Specific Application
PHASE II TRIAL OF 18F-FLUORIDE PET AS A
PHARMACODYNAMIC BIOMARKER
B. Study Requirements
This trial will use the radiopharmaceutical 18F-fluoride and will be performed under the National Cancer
Institute (NCI) IND. ACRIN will be contracting with manufacturers to provide the 18F-fluoride agent for
sites and ACRIN will pay for the cost of the agent and coordinate ordering options.
Sites will order the 18F-fluoride from ACRIN approved vendor(s). Information on how to obtain the 18Ffluoride will be provided by the project manager for the trial, Donna Hartfeil (dhartfeil@acrarrs.org)
Sites interested in producing their own 18F-fluoride may request approval from the NCI and should
contact Donna Hartfeil for further information, but sites are encouraged to obtain the agent from
the identified vendors.
The investigator brochure and section 4.0 in the protocol contain specific information related to
fluoride development and use.
Please provide the following information regarding the
18F-
18F-fluoride:
Please indicate the source of 18F-fluoride at your site:
Formulate on site*
ACRIN-contracted manufacturer
*Must be formulated per the NCI IND guidelines
A. If formulating on site, please record the individual responsible for preparing the 18F-fluoride.
Name and Title:
B. If obtaining from ACRIN, please record the person responsible for ordering and receiving the
fluoride.
18F-
Name and Title:
Telephone:
Radiochemist
Fax:
E-mail:
Radio Pharmacist
Other, specify:
If your center is formulating 18F-fluoride on site, please confirm compliance with the following:
Able to formulate 18F-fluoride according to the NCI IND specifications?
Able to perform pre-release pyrogen testing of final drug formulation?
Able to perform pre-release radiochemical purity testing of final drug formulation
as specified in the protocol?
ACRIN 6687 (v.4_12.28.09)
Yes
No
Yes
No
Yes
No
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ACRIN 6687 Protocol-Specific Application
PHASE II TRIAL OF 18F-FLUORIDE PET AS A
PHARMACODYNAMIC BIOMARKER
C. Imaging Equipment and Scanning Procedures
Please provide the following information for all PET/CT scanners to be used in this study.
Is the scanner either
ACR or ICANL
Accreditation expiration
Manufacturer
Model
accredited?
date(s)
See note.1
Yes
No
Yes
No
Yes
No
1
If a site does not have American College of Radiology (ACR) PET accreditation or the Intersocietal
Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL) for the PET scanner(s) that
will be used for this protocol, a PET QA Questionnaire must be submitted with the PSA. The PET QA
questionnaire can be found at the end of this application.
Is your site able to perform dynamic PET imaging according to the parameters
described in Section 10.1 of the protocol?
Yes
No
PET or PET/CT Qualification Process
ACRIN qualification of the PET/CT scanner is required prior to enrollment of study participants. This
qualification is independent and separate from the ACR or ICANL accreditation requirement noted above.
If the scanner to be used for this trial is already qualified by ACRIN, a site does not need to complete the
qualification application as long as the two-year PET qualification period has not expired. If the two-year
period has expired, a site will need to complete a new application.
The application instructions and the application form are available on the ACRIN web site at:
http://www.acrin.org/tabid/612/Default.aspx
D. Information Systems Technology
Each participating site is required to submit PET/CT and CT or Bone Scan images to the ACRIN Imaging
Core Laboratory. The preferred image transfer method is via TRIAD, a software application that ACRIN
provides for installation on a site’s PC. TRIAD collects image sets from a scanner’s computer or from the
picture archiving communications system (PACS). The TRIAD software anonymizes, encrypts and non
destructively compresses the images as they are transferred to the ACRIN image archive in Philadelphia.
Other options for image submissions include: via a secured file transfer protocol (sFTP) to a specified
location on the ACRIN server; or via a CD mailed to the ACRIN Imaging Core Lab. Plain/hard copy films
ACRIN 6687 (v.4_12.28.09)
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ACRIN 6687 Protocol-Specific Application
PHASE II TRIAL OF 18F-FLUORIDE PET AS A
PHARMACODYNAMIC BIOMARKER
will not be accepted. Each image submission must be accompanied by an Imaging Transmittal
Worksheet submitted via fax or mailed with CDs/DVDs.
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 specification to
support the TRIAD software:
 Operating System Windows XP Pro, Windows 2000 Server SP4 and
above and Windows 2003 server
 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 the installation of the TRIAD Software prior to first
accrual at Triad-Support @phila.acr.org or by phone at 215-940-8820
ACRIN Protocol Principal Investigator Confirmation
I,
(Name of Protocol Principal Investigator*) have reviewed and agree with
the information contained in this application and approve of its review by ACRIN’s Institutional
Participants Committee.
*Please submit an FDA 1572 form, current signed and dated CV and conflict of interest form along with
the completed PSA.
Application Submission Information:
Please e-mail the completed application to the ACRIN application email at: acrin_application@acrarrs.org and mail or fax the referring physician letter(s) to:
American College of Radiology
Attn: ACRIN 6687 PSA
Diagnostic Administration
1818 Market Street, Suite 1600
Philadelphia, PA. 19103-3604
Fax: 215-717-0936
ACRIN 6687 (v.4_12.28.09)
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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.
Complete this questionnaire only if you answered “NO” in section D (Imaging Equipment) to the
question concerning ACR or ICANL accreditation of the PET/CT machine.
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 three-year
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?
If yes, briefly describe:
yes
no
Electronic Signature and Title of the Person completing this QA Questionnaire:
Version Date: 12.15.05