Imaging Requirements (RTOG 1106/ACRIN 6697) Adam Opanowski, CNMT, PET, NCT, R.T.(N)(ARRT) Imaging Analyst ACR Core Laboratory

Transcription

1 Imaging Requirements (RTOG 1106/ACRIN 6697) Adam Opanowski, CNMT, PET, NCT, R.T.(N)(ARRT) Imaging Analyst ACR Core Laboratory

2 Imaging Qualification and Quality Control Patients must be scanned on PET/CT scanners that have been qualified by the ACRIN PET Core Lab A dedicated PET/CT scanner is mandatory A flat palette imaging couch is required Whenever possible, the same scanner should be used for both the FDG-PET/CT and FMISO- PET/CT

3 Imaging Qualification and Quality Control Requirements for ACRIN PET Qualification Uniform Phantom ( 18 F waterfilled) Test Patient Images (base of skull to mid-thigh) PET Qualification Application ORATORY/PETQUALIFICATION.aspx

4 FDG-PET/CT

5 FDG-PET/CT Patient Preparation Prior to injection, patient must fast for at least 4 hrs. Encouraged to be well hydrated prior to scan Blood glucose measurement is required and must be <200 mg/dl Height and weight must be measured on the day of the scan in the imaging department using calibrated and medically approved devices (not verbally relayed by the patient)

6 FDG-PET/CT Injection of FDG IV catheter access line (18 or 20 gauge is preferred) is placed in one arm (ideally contralateral [if accessible] to the side of the primary tumor) for the FDG injection The dose of FDG will be 8-20 mci depending on institutional procedure The dose entered into the DICOM header must be properly decay corrected to the time of injection A saline flush of at least 10 ml should follow the injection

7 FDG-PET/CT Injection of FDG The exact time of calibration of the dose should be recorded using a global time piece consistently used throughout the study for time recording The exact time of injection should be noted and recorded to permit correction of the administered dose for radioactive decay Any dose remaining in the tubing or syringe, or that was spilled during injection, should be recorded The injection should be performed through and IV catheter and 3-way stopcock

8 Decay Correction A decay correction excel worksheet will be provided to each site ACRIN website/imaging Materials Used to ensure the net administered activity entered into the scanner and ITW is accurate Only the dose assay, time of assay, residual activity, and residual time of assay can be entered all other cells are locked

9 FDG-PET/CT Imaging Procedure All PET exams should contain 3 transaxial whole body series, attenuated and nonattenuated corrected PET and CT images Imaging must begin 60 +/- 10 minutes after injection (50-70) The patient should empty his/her bladder immediately before the acquisition of images The patient should be positioned on the flat table imaging couch in treatment planning position

10 FDG-PET/CT Imaging Procedure The transmission scan should be a low-dose CT scan without IV contrast for the PET/CT, done before the emission scanning Oral contrast is permitted per institutional procedure The transmission scan type, length, etc., should exactly match that used in the calibration and qualification procedure An emission scan from skull base to mid-thigh at 2-5 min per bed position

11 FMISO-PET/CT

12 FMISO-PET/CT Ordering Dose ACRIN notifies Cardinal Verification of activation/participation Cardinal will contact site to provide ordering information 72 hrs. notice to schedule a patient (availability) Generally, FMISO is available in the afternoon, but some radiopharmacies can make product in the morning Dependent on production schedule

13 FMISO-PET/CT Patient Preparation No deliberate fasting is required Encouraged to be well hydrated prior to scan Blood glucose is not required Height and weight must be measured on the day of the scan in the imaging department using calibrated and medically approved devices (not verbally relayed by the patient) Vital signs, including temperature, blood pressure, heart rate, and respiratory rate, will be measured prior to injection of FMISO

14 FMISO-PET/CT Injection of FMISO IV catheter access line (18 or 20 gauge is preferred) is placed in one arm (ideally contralateral [if accessible] to the side of the primary tumor) for the FMISO injection The dose of FMISO must be 3.7 MBq/kg (0.1 mci/kg) (maximum 260 MBq, 7 mci) in < 10 ml Minimize the length of IV tubing between the injection site and the vein to avoid FMISO being left in the tubing

15 FMISO-PET/CT Injection of FMISO The exact time of calibration of the dose should be recorded using a global time piece consistently used throughout the study for time recording The exact time of injection should be noted and recorded to permit correction of the administered dose for radioactive decay Any dose remaining in the tubing or syringe, or that was spilled during injection, should be recorded The injection should be performed through and IV catheter and 3-way stopcock Adverse reactions also referred to as adverse events [AEs] must be solicited in open-ended fashion (i.e., how are you feeling )

16 Decay Correction A decay correction excel worksheet will be provided to each site ACRIN website/imaging Materials Used to ensure the net administered activity entered into the scanner and ITW is accurate Only the dose assay, time of assay, residual activity, and residual time of assay can be entered all other cells are locked

17 FMISO-PET/CT Injection of FMISO Please Note: AEs must be evaluated at each imaging session AE monitoring will cover at least 10 half-lives of the FMISO drug, or 24 hrs. AEs for FMISO are defined as any signs of illness or symptoms that have appeared or worsened since the infusion of the FMISO

18 FMISO-PET/CT Injection of FMISO Please Note: Participants must be queried for potential AEs at the following time points: At the time of injection Before leaving the PET suite If they call the site as instructed for any concerns during the 24 hours after FMISO administration By telephone up to 24 hours post-fmiso injection

19 FMISO-PET/CT (Vital Signs) Monitoring for Physiologic Effects of FMISO Section 6.13 of protocol Vital signs will be assessed both before and after injection of FMISO Time vital signs were measured Pulse Systolic and Diastolic BP Respiration Patient temperature

20 FMISO-PET/CT (AE)

21 FMISO-PET/CT Imaging Procedure All PET exams should contain 3 transaxial whole body series, attenuated and nonattenuated corrected PET and CT images Imaging of the chest (from apices to the base) will occur 2 hours +/- 10 minutes post injection ( ) The patient should empty his/her bladder immediately before the acquisition of images The patient should be positioned on the flat table imaging couch in treatment planning position

22 FMISO-PET/CT Imaging Procedure The transmission scan should be a low-dose CT scan ( kvp, 80 effective mas) without IV contrast for the PET/CT, done before the emission scanning A minute emission scan of the chest is performed focusing on the area of the primary tumor, with the left ventricle or aorta included in the FOV to be able to measure blood activity There should be at least 10 minutes per axial field of view. If greater than 3 axial fields of view are required to cover the lungs, a portion of the lungs may be excluded as far from the primary tumor as possible

23 FMISO-PET/CT Imaging Procedure The blood values for the scans will be derived from a region of interest (ROI) in a major vessel or cardiac chamber within the FOV Vital signs, including temperature, blood pressure, heart rate, and respiratory rate, are measured again at completion of the FMISO-PET/CT, and PRN (as needed) throughout the procedure

24 Imaging Forms FDG-PET/CT (TA) PET/CT Technical Assessment Form (EX) Dose Administration Treatment Exposure Form (TD) FDG-PET/CT Imaging-Related Drug History FMISO-PET/CT (TA) PET/CT Technical Assessment Form (EX) Dose Administration Treatment Exposure Form (SA) Safety Assessment Form

25 Imaging Forms It is highly recommended that each form is available for the Imaging Technologists on the day of the scan to be completed by the Technologist The Forms can be submitted through the ACRIN data center ( The forms can be found on the ACRIN website: ol6697/6697dataforms.aspx

26 Image Submission All imaging data should be transferred within 24 hours following the imaging session TRIAD ACRIN can provide software for installation on a PC at your site that collects, anonymizes, and submits image sets from your PET/CT system or from your PACS CD/DVD If needed, sites can submit imaging CD-ROM, the mode of shipment should include package tracking

27 Image Transmittal Worksheet (ITW) A completed, signed Image Transmittal Worksheet (ITW) MUST accompany all imaging exams submitted to ACRIN for each time point The ITW can be found on the ACRIN website under Protocol Summary Table at: agingmaterials.aspx Form exams submitted via TRIAD, complete the ITW and fax to or to imagearchive@acr.org

28 Image Transmittal Worksheet (ITW) Ensure ITW is fully and accurately completed If images are submitted via TRIAD, fax or ITW after submission is complete If images are sent via CD/DVD, the ITW must accompany the disk

29 Quality Control and Query Process Core Lab Imaging Technologist: Will perform image quality control (QC) If data discrepancies are identified during image quality control review, Imaging Technologist will issue a query Imaging queries will be ed to appropriate site personnel Queries should be resolved within five (5) business days Submit query forms via fax or Fax: imagearchive@acr.org

30 Imaging QC Issues Examples Missing or incomplete submission (image data and/or ITW) Corrupt media/unable to open images Discrepancy between ITW and DICOM header (e.g., weight, dose information) Data entry and/or calculation error on ITW

31 Thank you Support Materials can be found on the ACRIN website: Site Imaging Manual Imaging Requirements Slides Adam Opanowski, CNMT, PET, NCT, R.T.(N)(ARRT)