ACRIN PET Core Laboratory Qualification Instructions for PET/CT Scanners In ACRIN’s effort to continually improve the quality of images obtained in support of the group’s clinical trial research, important changes have been made to the ACRIN PET/CT Scanner Qualification process. Please review the recent program changes outlined below. Thank you! 1. All scanners for which a site is seeking ACRIN qualification must be a PET/CT scanner. PET ONLY scanners will no longer be accepted for qualification. Phantom must be a water-filled cylinder injected with 18F. 68Ga/68Ge solid cylinders are no longer acceptable. Uniform cylinder acquisition for trials involving PET/CT body scans must be acquired and reconstruction on a FOV of at least 500 mm diameter. A 2-bed position acquisition is required for the same duration as a 70 kg patient (generally 1.5 – 5 minutes per bed position). Uniform cylinder acquisition for trials involving PET/CT brain scans must be acquired and reconstructed on a FOV with a maximum diameter of 350 mm. A 1-bed position acquisition of a 10 minute duration is required for 3D acquisitions and a 20 minute duration is required for 2D acquisitions. For trials involving body or brain PET/CT scans that have a dynamic scanning component (even if it is optional), a uniform cylinder, acquired and reconstructed with a pre-defined dynamic protocol, must be submitted. Test Patient Studies are only required at the time of initial qualification. New Test Patient Studies are NOT required for requalification. 2. 3. 4. 5. 6. I. General ACRIN PET/CT Qualification Requirements (for both body and brain scans) a. Static Quantitative Imaging b. Dynamic Quantitative Imaging c. II. Quantitative Imaging with Well-Counter Cross-Calibration Materials Required Submit the following for every PET/CT scanner that will be used for ACRIN research. (Note: Separate phantoms and test patient studies are required for body and brain qualification): a. PET Qualification Application b. Uniform Phantom Images (DICOM) with Phantom Data Form(s) c. III. Two Test Patient Studies Uniform Phantom Acquisition Requirements a. Phantom preparation: i. Fill phantom with 18F, so that the concentration is 135 – 165 nCi/ml: 1. For standard GE phantom (5,640 ml): 0.75 – 0.95 mCi 2. For standard Siemens phantom (6,283 ml): 0.85 – 1.05 mCi 3. For standard Philips phantom (9,293 ml): 1.25 – 1.55 mCi Document1 Page 1 of 4 ACRIN PET Core Laboratory Qualification Instructions for PET/CT Scanners ii. See the Uniform Phantom Filling Instructions for details about recommended filling procedures. b. Phantom Acquisition (Note: Complete the acquisitions required for the type and level of qualification being sought.) i. Body FOV, Static Quantitative Imaging specifications: 1. FOV Diameter ≥ 500 mm 2. Time per Bed Position 1.5 – 5 minutes per bed position 3. Axial Extent 2 bed positions 4. Use standard reconstruction settings for clinical body studies ii. Body FOV, Dynamic Quantitative Imaging specifications: 1. FOV Diameter ≥ 500 mm 2. Dynamic Frame requirements (25 minutes total) a. 16 x 5 sec b. 7 x 10 sec c. 5 x 30 sec d. 5 x 60 sec e. 5 x 180 sec 3. Axial Extent 1 bed position 4. Additional processing requirements: A single-summed 25 minute image must be submitted 5. Use manufacturer recommended (or site specific) algorithm and settings for dynamic body studies unless otherwise specified for individual trial. iii. Body FOV, Quantitative Imaging with Well-Counter Cross-Calibration 1. Prior to acquiring the Static Body cylinder acquisition, follow the instructions detailed in the Cross-Calibration SOP to create and assay the aliquots for the well-counter. iv. Brain FOV, Static Quantitative Imaging specifications: 1. FOV Diameter ≤ 350 mm 2. Time per Bed Position 10 minutes for 3D acquisition or 20 minutes for 2D acquisition 3. Axial Extent 1 bed position 4. Use standard reconstruction settings for clinical brain studies Document1 Page 2 of 4 ACRIN PET Core Laboratory Qualification Instructions for PET/CT Scanners v. Brain FOV, Dynamic Quantitative Imaging specifications: 1. FOV Diameter ≤ 350 mm 2. Dynamic Frame requirements (Total of 25 minutes) a. 16 x 5 sec b. 7 x 10 sec c. 5 x 30 sec d. 5 x 60 sec e. 5 x 180 sec 3. Axial Extent 1 bed position 4. Additional processing requirements: A single summed 25 minute image must be submitted 5. Use manufacturer recommended (or site specific) algorithm and settings for dynamic brain studies unless otherwise specified for individual trial. vi. Brain FOV, Quantitative Imaging with Well-Counter Cross-Calibration 1. Prior to acquiring the Static Brain cylinder acquisition, follow the instructions detailed in the Cross-Calibration SOP to create and assay the aliquots for the well-counter. c. Uniform Phantom Image Submission: i. Prior to image submission, site should: 1. Check the images to ensure that they are free of artifacts 2. Review Image Analysis SOP to better understand the analysis that will be performed by the ACRIN Core Laboratory ii. All image data must be sent in uncompressed standard DICOM format iii. For all phantom studies, the site must submit: 1. Appropriate phantom data forms 2. CT images used for attenuation correction 3. PET attenuation corrected images 4. PET non-attenuation corrected images IV. Test Patient Submission a. Only two test patients must be submitted for each FOV, even if a site will be apply for multiple levels of qualification b. Test patients should undergo FDG-PET/CT scan that were acquired following the site’s standard clinical SOPs. Document1 Page 3 of 4 ACRIN PET Core Laboratory Qualification Instructions for PET/CT Scanners c. All image data must be sent in uncompressed standard DICOM format d. For all test cases, the site must submit: 1. Appropriate phantom data forms 2. CT images used for attenuation correction 3. PET attenuation corrected images 4. PET non-attenuation corrected images ** Test cases are only required for initial qualification. Requalification does not require new Test Patient Studies to be submitted. V. Image Transmission a. All image data must be sent in uncompressed standard DICOM format b. Visit the Qualification Utility in the Imaging Core Laboratory website to register for an account (https://quic.acr.org) c. Refer to the QUIC User Guide for instructions about uploading images d. Questions? E-mail: imagearchive@acr.org. Document1 Page 4 of 4