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

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

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

Courtesy: Paul E. Christian Scanner Constancy Courtesy: Paul E. Christian

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

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

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

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

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

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18F Fillable Phantom Repeat studies using a precision filling technique with F-18 Paul E. Christian, Keith Bigham, unpublished data 2008

Imaging Process 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

Evaluation Criterion: Clinical Simulation Phantoms Evaluate: 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

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

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

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

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

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

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

Scanner Validation Sub-Committee 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