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

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1 Centers for Quantitative Imaging Excellence LEARNING MODULE CQIE MRI PROCEDURES American College of Radiology Clinical Research Center Imaging Core Laboratory v.2

2 Centers for Quantitative Imaging Excellence LEARNING MODULE This module is intended to provide a general overview of the CQIE MRI 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 MRI Team Learning Modules Clinical Test Cases Phantom Tests ACR MRI & CQIE Body DCE-MRI Phantoms 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 / QC varying image acquisition protocols

7 CQIE Site Qualification Why standardize? Good Science - For results to be of benefit to researchers and patients, the results must be accurate and reproducible (across patients, timepoints, imaging equipment, institutions). Standardize imaging equipment (when possible) Standardize image/data acquisition Standardize image/data processing Standardize readers

8 CQIE Site Qualification Standardization of Quantitative MRI, DCE-MRI Patient preparation & positioning Contrast administration (dose, rate, timing) Data acquisition / imaging parameters Data reconstruction Quality control Input function (normalized versus measured) Kinetic modeling & analysis Challenges to Quantitative Imaging: Vendor-related variability - measurement results, imaging protocols Site-related variability - measurement results, protocol compliance

9 CQIE Qualification CQIE MRI Qualification Process Site Initiation Learning Modules Annual Qualification Imaging * Clinical Test Cases (MR brain diffusion) ACR MRI Phantom CQIE Body DCE-MRI Phantom Standardized QC Testing * * For each scanner to be qualified

10 SITE INITIATION MRI TEAM

11 Site Initiation Purpose: To familiarize the MRI 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.

12 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 MRI phantom scanning procedures and acquisition protocols Review of standardized QC testing Demonstration of phantom scans (on-site visits)

13 LEARNING MODULES

14 Learning Modules Modules for MRI Team: Complete as part of the site initiation process CQIE Overview CQIE MR Procedures Complete prior to T1 Introduction to Multicenter Imaging Trials Quantitative Imaging for Multicenter Trials (MR) Additional modules will be developed for T2-T3

15 QUALIFICATION IMAGING

16 Qualification Imaging MR Imaging Requirements: For each scanner to be CQIE-qualified MR Brain Diffusion (test case) Phantom Tests ACR MRI Phantom ACRIN will provide, on loan, if you do not own one. CQIE Body DCE-MRI Phantom ACRIN to provide. Images and data forms submitted to ACRIN for review / analysis

17 Qualification Imaging Clinical Test Case: MR Brain Diffusion Diffusion-weighted MR series from a live subject or volunteer (with or without findings) Preferably, acquired within past month Submit imaging data set to ACRIN, include post-processed reconstruction of ADC maps eadc or FA maps, if part of your routine imaging protocol

18 PHANTOM TESTS

19 ACR MRI Phantom Tests

20 ACR MRI Phantom Tests Phantom Scans: Brain Imaging CQIE-ACR Series Sagittal Locator Axial T1 Axial T2 Double-Echo CQIE Sagittal 3D Volumetric Protocol CQIE Brain DCE-MRI Protocol T1 Mapping (5 T1 scans) Axial Dynamic series (DCE)

21 ACR MRI Phantom Tests Purpose of the ACR MRI Phantom Tests: Provide means of evaluating scanner geometric accuracy, high contrast spatial resolution, slice thickness accuracy, slice position accuracy, image intensity uniformity, percent signal ghosting, and low contrast object detectability. Evaluate compliance with advanced MRI acquisition protocols.

22 ACR MRI Phantom Tests Refer to Appendix C1 of the CQIE Manual of Procedures (MOP) for detailed scan instructions

23 CQIE Body DCE-MRI Phantom Tests

24 CQIE Body DCE-MRI Phantom Tests Phantom Scans: Body DCE-MRI 3 Plane Localizer Body Coil Map 15 (tuned, with pre-scan) Array Coil Map 15 (not tuned, no pre-scan) T1 Map 30 (tuned, with pre-scan) T1 Map 15 (not tuned, no pre-scan) T1 Map 5 (not tuned, no pre-scan) Dynamic Scan 30 (not tuned, no pre-scan)

25 CQIE Body DCE-MRI Phantom Tests Purpose of the DCE-MRI Phantom Tests: Provide means for qualitative and quantitative evaluation, including T1 map error estimation, temporal resolution and image quality. Evaluate compliance with image acquisition protocols.

26 CQIE Body DCE-MRI Phantom Tests Refer to Appendix C2 of the CQIE Manual of Procedures (MOP) for detailed scan instructions

27 DATA SUBMISSION & ANALYSIS

28 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.

29 Data Submission Submit Image/Data Sets MR Brain Diffusion Test Case ACR-MRI Phantom Tests CQIE Body DCE-MRI Phantom Tests For all MR scanners to be CQIE qualified

30 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 queued for analysis.

31 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.

32 STANDARDIZED QUALITY CONTROL (QC)

33 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.

34 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.

35 Standardized QC Quality Control - MRI MR system stability To reduce system-level variance in longitudinal measurements, a robust quality control program is needed. Research is ongoing to develop standard, validated phantoms and processes for quantitative MR (QIBA, AAPM, ISMRM, NIST)

36 Standardized QC MRI Test Center Frequency Table Positioning Signal to Noise Artifact Analysis Geometric Accuracy High-Contrast Resolution Low-Contrast Resolution Magnetic Field Homogeneity Slice Position Accuracy Slice Thickness Accuracy Radiofrequency Coil Checks Minimum Frequency Weekly Weekly Weekly Weekly Weekly Weekly Weekly Quarterly Quarterly Quarterly Annually

37 References American College of Radiology. MRI Quality Control Manual, 2004 American College of Radiology. ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Magnetic Resonance Imaging Equipment, American College of Radiology. ACR Practice Guideline for Performing and Interpreting Magnetic Resonance Imaging, Quantitative Imaging Biomarkers Alliance (QIBA), Radiological Society of North America (RSNA). AAPM Working Group for Standards for Quantitative MR Measures. Imaging Working Group (IWG), Clinical Translational Science Awards (CTSA).

38 Qualification Checklist CQIE MR Qualification Requirements T0 T1 T2 T3 Learning Modules (2 per year) - CQIE Overview (T0) X X X X - CQIE MRI Procedures (T0) ACR MRI Phantom Tests X X X X CQIE Body DCE-MRI Phantom Tests X X X X Quality Control Questionnaire X X X

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