RTOG 1106 / ACRIN6697 FORM COMPLETION INSTRUCTIONS

Technical Assessment Form

The PET/CT Technologist should complete the form at the time of the PET/CT scan.

NOTE: These form completion guidelines only address certain specific form questions.

Additional form completion instructions can be found in the general form instructions document available on the ACRIN 6697 website. Contact data management for all form related questions/clarifications.

PartI.Exam Data

Question 3: Was imaging exam completed?

No: Select if the exam was not completed. If the exam was not done at all on the scheduled scan date, but will still be done prior to surgery, this form should not be completed until then. If the scan was not completed, but will be rescheduled, this form should be completed. If the exam was not done at all and will not be rescheduled, a PR (Protocol Violation) form will be required. Q3a-6 are still required.

Yes:Select if the exam was completed.

Question 3a:If imaging not completed, provide reason: If Q3 is answered “no”, this question is required. Select the single best reason imaging was not completed. The rest of the form still must be completed, but “Not done” may be selected for any section which had no information collected.

Question 4:Date of imaging: This question is required if the participant came to the imaging center and should be provided even in the event they are not injected/imaged. If the participant missed their imaging appointment for any reason, the schedule date of the exam should be provided.

5. Subject weight This must be recorded in kg and taken on the day of the PET/CT scan.

6. Subject height This must be recorded in cm and taken on the day of the PET/CT scan.

Part II. Patient Preparation

If information for this section was not collected, check “Not done” and skip to Part III. If information was collected, this section is required and “not done” should not be checked.

This section should only be completed for FDG-PET/CT scans. For FMISO-PET/CT scans, the “not done” box should be checked.

Part III. Scanner

If information for this section was not collected, check “Not done” and skip to Part IV. If information was collected, this section is required and “not done” should not be checked.

Question 2: Has the scanner used for this study been qualified by ACRIN?: The PET/CT scanner used for study imaging must be qualified by ACRIN (refer to section 9.0 of the protocol for the Imaging Protocol and PET/CT scanner qualification information). If the scanner is ACRIN approved, please provide the ACRIN scanner ID. If it is not approved, please specify why and provide the manufacturer and model number of the scanner in Q3.

Questions 4 and 5: Date of last PET scanner SUV validation and Daily scanner QC run on date of study?: These questions are required if the scanner is qualified by ACRIN and optional if it is not.

Part IV. Transmission Scan

If information for this section was not collected, check “Not done” and skip to Part V. If information was collected, this section is required and “not done” should not be checked.

Part V. PET Emission Scan

If information for this section was not collected, check “Not done” and skip to Part V. If information was collected, this section is required and “not done” should not be checked.

Part VI. Adverse Events

Question 1: Any adverse events related to imaging to report for this timepoint?: Please refer to section 7.8 of the protocol for FDG-PET/CT AE reporting guidelines or appendix VII for FMISO-PET/CT reporting guidelines. If an AE of any grade occurred, Q2 is required.

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