ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
Please complete the Protocol-Specific Application (PSA) in electronic format. This will
expedite the processing of the application and help maintain correct information on file.
Contact ACRIN 6685 protocol manager Irene Mahon (Ph: 215-574-3249 and/or Email:
imahon@acr.org ) should you have any questions.
Name of Site:
Address:
A. Study Team
Nuclear Medicine Physician/Radiologist (Attach CV):
Address:
Telephone:
Fax:
E-mail:
ACRIN Research Associate/Coordinator:
Address:
Telephone:
Fax:
E-mail:
The RA will need to coordinate activities such as scheduling of imaging scans, communication with
referring oncologists and oncology staff regarding participant enrollment and actively engage in other
enrollment activities as appropriate for processes at the site.
Will the RA listed above be able to carry out these activities?
Yes
No
Lead PET/CT Technologist:
Address:
Telephone:
Version Date: 2.7.2013
Fax:
E-mail:
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
Supporting Surgeon and Oncologist
A critical success factor for participant accrual will be the support of referring surgeons, oncologists, and
their staff to identify potential participants, assist with the consent process, and coordinate treatment and
imaging schedules.
Please identify at least one surgeon and one oncologist who are willing to serve as lead referring
physicians at your site and perform the responsibilities listed on the Primary Surgeon and Oncologist
Support Acknowledgement form attached to the application.
Primary Supporting Surgeon:
Address:
Telephone:
Fax:
E-mail:
Primary Supporting Oncologist:
Address:
Telephone:
Fax:
E-mail:
Fax:
E-mail:
Fax:
E-mail:
Oncology RN/Coordinator:
Address:
Telephone:
Pathologist:
Address:
Telephone:
Version Date: 2.7.2013
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
B.
Information Systems Technology
Sites are required to submit PET/CT and MRI images 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
 Access to the Internet: Internet Explorer
 A 100 GB hard drive is preferred
 At least 512 GB 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.
C. Imaging Equipment
PET/CT Scanner(s) used for ACRIN 6685:
Manufacturer
Version Date: 2.7.2013
Model
Is the scanner either
ACR or ICANL
accredited?
Yes
No
Yes
No
Yes
No
Accreditation
expiration date(s)
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
Does/do your dedicated ACRIN 6685 PET/CT scanner(s) meet the scanner
requirements listed in the protocol (section 9.3) and noted below?
Yes
No

PET/CT scanner capable of performing both emission and CT transmission images in
order to allow for attenuation corrected PET/CT scan images.

PET/CT scanner capable of calculating standardized uptake values (SUVs).
Compliance with the manufacturer’s recommendations for assessing scanner
calibration and QC guidelines is required.

Is your site able to perform the PET/CT scan acquisition according to the
parameters described in the protocol and noted below (complete guidelines
in protocol section 9.0)?
Yes
No

Obtain height & weight on calibrated device and obtain serum glucose prior to PET/CT.

FDG dose of 1-20 mCi, adjusted for wt, and prepared in accordance with USP
standards; record exact time of dose calibration and injection (~ 60 minutes prior to
imaging.
Scan from the orbit through the lower pelvis in position recommended by the protocol.


Acquisition parameters for low dose CT: kV 120, effective mAs 30-80, gantry rotation
<0.5 sec, maximum reconstruction width 3-5 mm without overlap, and without iodinated
contrast.
ACRIN qualification of the PET or PET/CT scanner is required prior to enrollment of study
participants. This qualification is 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 6685 protocolspecific Web page (click on the “Imaging Materials” section) at
www.acrin.org/6685_protocol.aspx.
If applicable, has your site submitted the ACRIN 6685 PET qualification
Yes
No
application and images?
If no, please provide a date by when they will be submitted:
Version Date: 2.7.2013
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
D. Participant Recruitment
1. Trial Specific Recruitment Goal
A total of 292 study participants with newly diagnosed head and neck squamous cell carcinoma
considered for surgical resection with at least one side of the neck clinically N0 will be recruited
for this study. Recruitment is expected to take approximately 24 months.
2. Historical Volume
Please provide the following information regarding your site’s potential to enroll patients in the
trial.
Number of patients treated at your site in 2011 & 2012
undergoing surgical resection for head and neck
squamous cell carcinoma with at least one side of the
neck clinically N0.
2011
2012
Indicate from what source(s) the above patient volume information was obtained:
Oncology Practice Database
Hospital Information System
Other, please specify:
3. Participant Recruitment Potential
Please provide a realistic estimate of the minimum number of patients who can be
enrolled into the trial annually at your site?
Provide an explanation for any significant discrepancy between the minimum number of
patients and historical volume reported above.
Please record the key processes for identifying and enrolling patients at your site that have
been discussed with the supporting surgeon and oncologist.
Version Date: 2.7.2013
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
4. Recruitment Tools
ACRIN will support recruitment at participating sites with a variety of recruitment tools. To help us
plan and prioritize their production, please rate how likely you are to use the following tools.
Please note: all patient recruitment materials must be IRB approved prior to use.
Recruitment Tool
Very
Likely
Likely
Somewhat
Likely
Not
Likely
PowerPoint presentation to inform referring
clinicians about the study.
Template letters to send to referring clinicians
(oncologists, surgeons, primary care physicians)
informing them about the trial and soliciting their
support to recruit patients.
Study brochure for clinicians to give to their
patients who are eligible to participate.
Regular trial updates sent to identified referring
physicians.
Other?
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 a current CV along with the completed protocol specific application.
Application Submission Information:
Please e-mail the completed application to: acrin_application@acr.org (preferred delivery)
To mail or fax the application and materials:
American College of Radiology
Attn: ACRIN 6685 PSA
Diagnostic Administration
1818 Market Street, Suite 1600
Philadelphia, PA. 19103-3604
Fax: 215-717-0936
Version Date: 2.7.2013
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ACRIN 6685 PROTOCOL SPECIFIC APPLICATION
PET/CT Staging of Head & Neck Cancer and
its Impact on the N0 Neck Surgical Treatment
Primary Surgeon and Oncologist Support Acknowledgement
Thank you for your willingness to serve as the primary surgeon or oncologist for your practice in
support of the ACRIN 6685 trial, “PET/CT staging of head and neck cancer and its impact on
the N0 neck surgical treatment”. As a primary contact, your participation is essential to the
success of the study and timely accrual. Following are the general responsibilities you will need
to perform.
1. Become familiar with the study protocol.
2. Coordinate communication about the trial with the other participating physicians in your
practice.
3. Assist with patient recruitment by ensuring a coordinated process is in place to identify
eligible participants and refer potential participants.
4. Report any barriers related to participant enrollment on occasional conference calls.
5. Discuss the protocol with potential participants and coordinate patient consent process.
6. Ensure timely scheduling of imaging scans especially supporting scanning of the participant
on the trial-qualified PET/CT scanner within 14 days prior to surgery.
7. Ensure efficient and timely data collection by providing requisite clinical information.
8. Assist with providing vital status information and additional information regarding disease
progression on accrued participants.
Please acknowledge that you have read and understand these responsibilities by entering your
electronic signature below.
Primary Surgeon:
Date:
Primary Oncologist:
Date:
Version Date: 2.7.2013
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