NRG GY006 Requirements
Once your institution has completed all credentialing steps, please fill out the credentialing status inquiry form. If you were previously credentialed to participate in a similar protocol or have a question about your status for this protocol, you can complete the CSI form and IROC Houston will inform you of any outstanding requirements.
This trial will utilize TRIAD for dosimetry digital treatment data submission. TRIAD is the American College of Radiologys (ACR) image exchange application and it is used by NRG. See here for information on installing TRIAD.
For this study, credentialing is required for 3D CRT. In order to complete the 3DCRT credentialing process the following items must be completed:
All participants are asked to complete the Facility Questionnaire.
The PET/CT scanner must be qualified/credentialed prior to enrollment of patients. The qualification requirement is Static Body Quantitative (PET Body Quantitative-PTBO). For forms and information about how to qualify your PET/CT scanner, please visit https://quic.acr.org or contact Rebecca DiGati at rdigati@acr.org and imagearchive@acr.org or 215-574-3175. The following must be submitted for each PET/CT scanner to be used to scan NRG-GY006 trial participants (see note below):
PET Qualification Application,
Two test patient studies (FDG studies acquired in the last 30 days),
18F Water-filled Uniform Phantom images (DICOM) with the SUV measurement.
For this study, credentialing is required for IMRT. In order to complete the IMRT credentialing process the following items must be completed:
All participants are asked to complete the Facility Questionnaire.
Irradiate the IROC Houston's H&N phantom. Please fill in the request form online.
A previous patient from the institution needs to be planned per protocol (For credentialing dry run case, please only plan with the 45Gy prescription no SIB prescriptions) and submitted via TRIAD to go through the ABM (Active Bone Marrow), KBP (Knowledge Based Planning), and pre-treatment processes. Click here for step by step directions.
The PET/CT scanner must be qualified/credentialed prior to enrollment of patients. The qualification requirement is Static Body Quantitative (PET Body Quantitative-PTBO). For forms and information about how to qualify your PET/CT scanner, please visit https://quic.acr.org or contact Rebecca DiGati at rdigati@acr.org and imagearchive@acr.org or 215-574-3175. The following must be submitted for each PET/CT scanner to be used to scan NRG-GY006 trial participants (see note below):
PET Qualification Application,
Two test patient studies (FDG studies acquired in the last 30 days),
18F Water-filled Uniform Phantom images (DICOM) with the SUV measurement.
Note:
Institutions that are credentialed to participate in other RTOG IMRT protocols requiring an IMRT H&N or spine phantom irradiation need not repeat the phantom irradiation for credentialing for this protocol.
Pre-treatment reviews are required for each IMRT case. These should be submitted via TRIAD.
Requalification of the PET/CT scanner must occur for any of the following scenarios:
One year from the initial qualification approval.
A new scanner is installed that will be used to scan trial participants.
Any PET/CT system that undergoes a major upgrade (i.e. any upgrade that may affect the SUV).
Per the protocol (Section 5.7), Once sites are credentialed for IG-IMRT they must commit to treating all patients they enroll on the protocol with this technique. This means that if a site is previously credentialed to treat with 3DCRT, and is now credentialed for IMRT, the IMRT credentialing will overwrite the 3DCRT credentialing, and the site must treat all patients with IMRT (not 3DCRT ).