CQIE PET PROCEDURES. American College of Radiology Clinical Research Center. Centers for Quantitative Imaging Excellence LEARNING MODULE

Transcription

1 Centers for Quantitative Imaging Excellence LEARNING MODULE CQIE PET PROCEDURES American College of Radiology Clinical Research Center Imaging Core Laboratory v2.1

2 Centers for Quantitative Imaging Excellence LEARNING MODULE This module is intended to provide a general overview of the CQIE PET procedures. All participants are urged to review the CQIE Manual of Procedures (MOP) for further details. CQIE MOP and program information: After you ve reviewed this module please let us know by submitting the learning module attestation. The link is provided at the end of this module.

3 Centers for Quantitative Imaging Excellence LEARNING MODULE CQIE Site Qualification Process Site Initiation PET Team Learning Modules Clinical Test Cases Phantom Tests Uniform Cylinder & ACR PET Phantom Data Submission / Analysis Standardized Quality Control

4 CQIE Site Qualification Qualify NCI cancer centers to participate in future NCI clinical trials in which there is a quantitative imaging component. Qualify NCI cancer centers in the following quantitative imaging methodologies: Volumetric CT (body), Volumetric MRI (brain) DCE-MRI (body and brain) Static and dynamic PET, PET/CT (body and brain) Provide imaging team with introduction to multicenter imaging trials

5 CQIE Site Qualification The CQIE qualification requirements are designed to qualify scanners qualify site imaging capabilities promote imaging standardization (harmonization) within multicenter clinical trials

6 CQIE Site Qualification Why standardize? Standardization of imaging is essential for trials in which imaging plays a central role in the research aim / endpoint. Standardization helps control / limit the inter- and intra-variability inherent in multicenter imaging trials due to multiple radiologists / image interpretation multiple technologists / image performance varying make/models of imaging equipment varying image quality varying image acquisition protocols

7 CQIE Site Qualification Why standardize - PET Technical Factors Affecting SUV Dose calibrator accuracy Scanner normalization, calibration Scan acquisition parameters Image reconstruction algorithm PET corrections: attenuation, scatter, randoms, decay ROI definition/methods for SUV Normalization factor in SUV (body weight, body surface, lean body mass) Daily, weekly, monthly scanner QC Technical and clinical factors affecting accurate and reproducible SUV, and the importance for standardization, will be discussed further in subsequent modules

8 CQIE Qualification PET Qualification Process Site Initiation Learning Modules Annual Qualification Imaging * Test Cases (body and brain) Uniform Phantom (static and dynamic) ACR PET Phantom (static and dynamic) Standardized QC Testing * * For each scanner to be qualified

9 SITE INITIATION PET TEAM

10 Site Initiation Purpose: To familiarize the PET team with CQIE qualification requirements phantom scans and standardized QC testing. To provide assistance with technical issues associated with standardizing imaging acquisition protocols across multiple models, platforms, and software versions.

11 Site Initiation Site initiation options: On-site initiation visit Teleconference with ACRIN-CQIE team Site initiation includes: Review of qualification requirements and timeline Review of PET phantom scanning procedures and acquisition protocols Review of standardized QC testing Demonstration of phantom scans (on-site visits)

12 LEARNING MODULES

13 Learning Modules Modules for PET Team: Complete as part of the site initiation process CQIE Overview CQIE PET Procedures Complete prior to T1 Introduction to Multicenter Imaging Trials Quantitative Imaging for Multicenter Trials (PET)

14 CLINICAL TEST CASES

15 Clinical Test Cases Set up Secure File Transfer Protocol (sftp) for image transmission: FTP is the protocol for exchanging files over the Internet. FTP works in the same way as HTTP for transferring web pages from a server to a user's browser and SMTP for transferring electronic mail across the Internet in that, like these technologies, FTP uses the Internet's TCP/IP protocols to enable data transfer. Refer to Appendix A-2 of the CQIE MOP for detailed instructions.

16 Test Cases Test Cases 2 Whole Body, 2 Brain * PT & P1 data forms * Submit prior to site visit. If declining PET site visit, submit prior to performing phantom scans. ACRIN will review for quality issues & will work with site staff to resolve technical/quality issues. * For each scanner to be qualified

17 Test Cases Test Cases 2 Whole Body, 2 Brain Any FDG study, with or without findings Acquired and reconstructed per your standard imaging protocols Preferably, performed within the past month Submit attenuation-corrected & non-attenuation corrected PET images (& CT images, if PET/CT)

18 PHANTOM TESTS

19 Phantom Tests Baseline and annual phantom tests * Uniform Cylinder ACR PET Phantom if you do not own an ACR PET phantom ACRIN will provide one on loan. Images and data forms submitted to ACRIN for review / analysis * * For each scanner to be CQIE qualified.

20 UNIFORM CYLINDER PHANTOM SCANS

21 Uniform Cylinder Phantom Scans Uniform Cylinder Phantom Used to evaluate the uniformity and noise characteristics of a given PET or PET/CT scanner Has the ability to highlight potential issues with normalization and/or quantitative calibrations

22 Uniform Cylinder Phantom Scans Acceptance Criteria Body and Brain FOV Static Acquisitions: Volume-averaged SUV in phantom, Axial variation in phantom <10% Body FOV Dynamic Acquisition: Volume-averaged SUV of each time frame varies by 10% over the course of the 25-minute acquisition

23 Uniform Cylinder Phantom Scans Uniform Cylinder Phantom Any fill-able, cylindrical phantom that does not have internal structures Should have an internal diameter of cm ACR PET phantom can be used for the uniform phantom scans as long as the cold rods and cold spheres are removed and the flat lid is used, not the lid with the cylinders attached (NOTE: It is highly recommended that a separate cylindrical phantom be used for the uniform phantom scans)

24 Uniform Cylinder Phantom Scans Required Materials: 1 Uniform Cylinder phantom 1 60 ml syringe 1 tuberculin syringe Clock or Timer CQIE PET data forms (P2) Dose - amount scaled to phantom volume, as described in scan instructions (appendix D1) FDG or F-18 fluoride are acceptable.

25 Uniform Cylinder Phantom Scans Uniform Cylinder Scans include: Acquired & reconstructed per your site s standard imaging protocol Body FOV static acquisition, two bed position, using the settings for a 70 kg patient (~24 BMI) Brain FOV, one bed position, 10 or 20 minute static acquisition Acquired & reconstructed per CQIE standardized imaging protocol Body FOV dynamic acquisition, one bed position

26 Uniform Cylinder Phantom Scans Refer to Appendix D1 of the CQIE Manual of Procedures (MOP) for detailed scan instructions

27 ACR PET PHANTOM SCANS

28 ACR PET Phantom Scans If you don t own a ACR PET Phantom ACRIN will provide one, on loan, for baseline and annual CQIE qualification imaging. The ACR PET Phantom will allow for the evaluation of the quantitative accuracy and the hot - and cold -object contrast resolution of a given PET, PET/CT scanner.

29 ACR PET Phantom Scans SUV Acceptance Criteria Based on the ACR s New 2010 Pass/Fail Critieria Mean Background: mm cylinder: > mm / 25 mm ration: > 0.7

30 ACR PET Phantom Scans Required Materials 1 ACR PET Phantom 1-1,000 ml bag/bottle of distilled water or saline solution 2 tuberculin syringes (for measuring Doses A and B 3 large syringes (60 ml) 3 large-bore needles (18 gauge) Clock or timer CQIE-ACR PET Phantom Dilution Worksheet CQIE PET data forms (P4, P5) Dose: FDG or F-18 fluoride are acceptable (most vendors provide F-18 fluoride for calibration/testing of scanners at a significantly lower price than FDG

31 ACR Flangeless PET Phantom

32 ACR PET Phantom Scans ACR PET Phantom Scans include: Acquired & reconstructed per your site s standard imaging protocol Body FOV static acquisition, two bed position, using the settings for a 70 kg patient (~24 BMI) Brain FOV, one bed position, 10 or 20 minute static acquisition

33 ACR PET Phantom Scans

34 ACR PET Phantom Scans Refer to Appendix D2 of the CQIE Manual of Procedures (MOP) for detailed scan instructions

35 ACR PET Phantom Scans SUV Analysis SUV analysis will be performed by ACRIN as part of the CQIE qualification analysis. Sites should perform their own SUV analysis to compare against acceptance criteria before submitting to ACRIN. To perform SUV analysis, use your preferred software package to sum together data and produce 9 12 mm thick data sets (for both the Brain and Body FOVs).

36 ACR PET Phantom Scans SUV Analysis 1. Select the 9 12 mm transverse slice that best shows the four hot cylinders.

37 ACR PET Phantom Scans SUV Analysis 2a. Draw a 2D circular background ROI, 6-7 cm in diameter, in the center of the chosen transverse slice (avoid cylinders). b. Draw a 2D circular ROI just inside the boundaries (as visualized on PET) of the largest hot cylinder (25 mm cylinder) c. Place copies of this smaller ROI over the other visible cylinders, including the air, water and bone cylinders

38 ACR PET Phantom Scans SUV Analysis 3. Save a screen capture of the image from step 2; all ROIs should be visible.

39 ACR PET Phantom Scans SUV Analysis 4. Record mean and max SUVs for each ROI in the appropriate section of the CQIE ACR PET Phantom SUV Analysis Form (P5), use separate forms for Brain and Body FOVs. Hot Vial 8 mm Hot Vial 12 mm Hot Vial 16 mm Hot Vial 25 mm max SUV Background Bone Air Water mean SUV min SUV

40 DATA SUBMISSION & ANALYSIS

41 Data Submission All image data should be transmitted to ACRIN via sftp: Secure File Transfer Protocol (sftp) is the protocol for exchanging files over the Internet. FTP works in the same way as HTTP for transferring web pages from a server to a user's browser and SMTP for transferring electronic mail across the Internet in that, like these technologies, FTP uses the Internet's TCP/IP protocols to enable data transfer. Refer to Appendix A-2 of the CQIE MOP for detailed instructions.

42 Data Submission Uniform Cylinder Phantom Tests attenuation-corrected PET data set non-attenuation-corrected PET data set CT data set (if PET/CT) ACR PET Phantom Tests attenuation-corrected PET data set non-attenuation-corrected PET data set CT data set (if PET/CT) CQIE PET data forms P2, P3, P4, P5

43 Data Analysis Upon receipt of the image data, the ACRIN Imaging Core Laboratory will perform a submission-level QC review to determine whether each modality-specific data set is complete and ready for evaluation If a discrepancy is found, ACRIN will contact the site for resolution of the discrepancy Once the modality-specific data set has passed the submission-level QC, the image data will be tagged for evaluation

44 Data Analysis Analyses will include qualitative and quantitative assessments performed at the ACRIN imaging core lab. Each submission will receive a Pass/Fail score based on modality-specific criteria. ACRIN will work with each site to identify and remedy deficiencies resulting in one or more Fail scores. Sites must pass at least one scanner for each of the imaging methods (CT, MR, PET) to become CQIE qualified.

45 STANDARDIZED QUALITY CONTROL (QC)

46 Standardized QC QC is an important function of image quality and patient safety. Benefits of routine QC include verification of operational integrity of imaging systems early identification of technical issues consistent, high image quality consistent quantitative accuracy Quantitative imaging increases importance of QC. Multicenter trials increases the importance of QC.

47 Standardized QC Standardized QC helps to ensure the quantitative data generated within a clinical trial is comparable within an institution and across institutions. Sites are expected to incorporate the CQIE standardized QC measures into their existing QC activities. Sites are required to adhere to the CQIE standardized QC measures to maintain qualification status.

48 Standardized QC PET, PET/CT Test Purpose Frequency Physical Inspection To check gantry covers in tunnel and patient handling system. Daily Daily Detector Check To test and visualize proper functioning of detector modules. Daily Blank Scan Normalization Uniformity Attenuation-Correction Calibration Cross-Calibration Spatial Resolution Count Rate Performance Sensitivity Image quality Visually inspect sonograms for apparent streaks and consistency. To determine system response to activity inside the field of view (FOV). To estimate Axial Uniformity across image planes by imaging a uniformly filled object. To determine calibration factor from image voxel intensity to true activity concentration. To identify discrepancies between the PET camera and the dose calibrator. To measure spatial resolution of point source in sinogram and image space. To measure count rate as a function of given activity concentration. To measure the volume response of the system to a source of given activity concentration. To check hot and cold spot image quality of standardized image quality phantom. Daily At least 1 x 3 months, after software upgrades and hardware service After maintenance, new setups, normalization, and software upgrades At least 1 x 6 months, after normalization At least 1 x 3 months, after upgrades, new setups, normalization At least annually After new setups, normalization, recalibrations At least 1 x 6 months At least annually

49 Standardized QC - CT Test Standardized QC Tests for CT (as part of PET/CT) PET-CT alignment CT Phantom Scan: - CT Number Accuracy of Water - Image Noise - Image Uniformity - Artifact Assessment Alignment Light/Slice Positioning Accuracy Imaged Slice Thickness (SSP) High-Contrast (Spatial) Resolution Low-Contrast Sensitivity and Resolution CT Number Scale Accuracy and Stability Dose Profile Width CTDI Frequency At least monthly Daily At least 1 x 3 months At least 1 x 3 months At least 1 x 3 months At least 1 x 6 months At least 1 x 3 months At least 1 x 3 months At least 1 x 6 months Documentation of the tests are subject to audit on annual renewal for qualification

50 Standardized QC Dose Calibrator Test Constancy (precision) Clock Accuracy Linearity Accuracy Geometry (position and volume) Frequency Each day of use and after equipment repair Daily Quarterly Annually and after equipment repair Upon installation and after replacement or repair of the chamber Documentation of the tests are subject to audit on annual renewal for qualification

51 References European Association of Nuclear Medicine Physics Committee. Routine quality control recommendations for nuclear medicine instrumentation. Eur J Nucl Med Imaging. 2010; 37: Boellard R, O Doherty MJ, Weber W, et al. FDG PET and PET/CT: EANM procedure guidelines for tumor PET imaging: version 1.0. Eur J Nucl Med Mol Imaging Boellard R. Standards for PET Image Acquisition and Quantitative Data Analysis. J Nucl Med. 2009; 50:11S-20S. RSNA Quantitative Imaging Biomarkers Alliance (QIBA), qibawiki.rsna.org/index.php?title=fdg-pet American Association of Physicists in Medicine. Quality control in diagnostic radiology. AAPM Report No. 74, July American College of Radiology. ACR Technical standard for medical nuclear physics performance monitoring of PET-CT imaging equipment, American College of Radiology. ACR Technical standard for medical nuclear physics performance monitoring of PET imaging equipment, American College of Radiology. ACR Technical standard for diagnostic procedures using radiopharmaceuticals, 2006.

52 Qualification Checklist CQIE Qualification Requirements T0 T1 T2 T3 Test Cases (2 Whole Body, 2 Brain) - 2 Whole Body, 2 Brain X X X X - PT and P1 Data Forms Uniform Cylinder Phantom Scans - Image Sets X X X X - P2 Data Form ACR PET Phantom Scans - Image Sets X X X X - P4 and P5 Data Forms Quality Control Questionnaire X X X

53 Qualification Summary Initial qualification (T0) Application, Site Assessment Form, MOU Site Initiation Visit (on-site or teleconference) CT, MR, PET qualification imaging/data forms Implementation of standardized QC measures Annual qualifications (T1-T3) CT, MR, PET qualification imaging/data forms Ongoing compliance with standardized QC Annual QC Questionnaire

54 ACRIN Please follow the link below to report your review of this module CQIE PET questions should be directed to American College of Radiology Clinical Research Center 1818 Market Street - Suite 1600 Philadelphia, PA Thank you!