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Purpose: Ensure scanner meets certain performance criterion needed for multi-center clinical trials via a clinical simul

Scanner Validation via the SNM Clinical Trials Network Phantom Program Paul E. Christian Molecular Imaging Program Huntsman Cancer Institute University of Utah. Scanner Validation Sub-Committee.

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Purpose: Ensure scanner meets certain performance criterion needed for multi-center clinical trials via a clinical simul

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  1. Scanner Validation via the SNM Clinical Trials Network Phantom ProgramPaul E. ChristianMolecular Imaging ProgramHuntsman Cancer InstituteUniversity of Utah

  2. Scanner Validation Sub-Committee Purpose:Ensure scanner meets certain performance criterion needed for multi-center clinical trials via a clinical simulation phantom exercise.

  3. Validate scanner performance • PET lesion detectability not consistent across vendors. • Imaging/processing protocols not consistent between sites. • SUV measurements not consistent across vendors nor sites. • PET data submitted to FDA for multi-center drug studies not deemed reliable. • Goal: Generate measurement tool to validate reliable multi-center PET data

  4. Quality Control • Dose Calibrator • CT Scanner • CT checks • Calibration • Inspection • PET Scanner • Blank scan • Constancy • PET and CT alignment • Record of PMs and calibrations

  5. Scanner Constancy Courtesy: Paul E. Christian

  6. Commonly Used PET Phantoms Commercial phantoms IEC NEMA NU-2 ACRIN ACR AAPM QIBA CROs

  7. NEMA-IEC NU-2 Phantom 68Ge resin filled phantom 270.8 day T1/2 4.6 mCi Bkgd 0.44 mCi/ml Spheres 1.75 mCi/ml 4:1 sphere/background ratio Atten Coeff 0.103 mm2/g at 511keV 59+-7 HU

  8. Ten Sites, Three vendors(GE 4-PET/CT, 2-PET; Philips 1-PET/CT; Siemens 3-PET/CT) Kinahan, Doot, U Wash.

  9. CTN Oncology Chest Phantom • Clinical simulator to measure: • Lesion detectability • Lesion quantitation • Image noise / texture

  10. CTN Oncology Chest Phantom • Fill with F-18 FDG • Precision Filling Technique • Clinical Concentration • Fixed Lesion/Background Ratio

  11. Precision 18F Fillable Phantom Repeat studies using a precision filling technique with F-18 Paul E. Christian, Keith Bigham, unpublished data 2008

  12. Fill phantom (precise technique) • Performing imaging according • to prescribed protocol • Image after specific time delay • Reconstruction parameters • MD to identify lesions • Submit images for review • Quantitative measurements (SUVmax and SUVave) • At site • At core lab Imaging Process

  13. Clinical Simulation PhantomsEvaluate: Image performance -Accuracy of dose -Acquisition -Reconstruction/filter -Interpretation # Lesions detected Location of detected lesions SUV measurements (site) -Verify SUVs at core lab -Evaluate DICOM images (core lab) Image quality of PET/CT scanner -Uniformity -Resolution -Contrast -Noise -PET/CT alignment -Lesion detectability -Attenuation correction -Quantitative accuracy Evaluation Criterion:

  14. Scanner Quantitative Validation Assessment: SUV background accuracy Lesion SUV accuracy DICOM transfer valid Validation of SUV DICOM

  15. 17 scanners validated to date • 13 sites • 11 more sites have phantoms • 20+ additional sites scheduled (worldwide expansion) Scanner Validation Progress

  16. DICOM image compatibility • Ability to provide quantitative images • Ability to provide accurate SUVs • Scanner operation/calibration • Dose calibrator Scanner Validation Site Problems

  17. Scanner Validation Sub-Committee 2010 Goals: Testing brain imaging phantom

  18. 2010 Goals: Testing myocardial perfusion imaging phantom (3 clinical scenarios) Scanner Validation Sub-Committee

  19. Scanner Validation Sub-Committee Accomplishments: • Development of scanner validation process • Implement review and quality assurance testing • Provide on-line phantom instructional video • Administration of oncology demonstration project • Oncology phantom imaging at 40+ sites • Development of myocardial perfusion phantom • Development of brain phantom

  20. 2010 Goals: Streamline phantom qualification program Develop central archive for images Develop process for long term maintenance and administration of phantom site qualification Implement multi-site testing of brain and cardiac phantoms Scanner Validation Sub-Committee

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