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QIBA Proposed Phase 1A Project V5.0

QIBA Proposed Phase 1A Project V5.0. QIBA Phantom Subgroup. Outline of proposal. Modified 1A reader study Outstanding issues. Draft 1A: Study objective. Measure intra- and inter reader bias and variability on phantom lesions for: Uni-dimensional size measurement

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QIBA Proposed Phase 1A Project V5.0

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  1. QIBAProposed Phase 1A ProjectV5.0 QIBA Phantom Subgroup N Petrick RSNA QIBA Phantom Group November 13, 2008

  2. Outline of proposal • Modified 1A reader study • Outstanding issues N Petrick RSNA QIBA Phantom Group November 13, 2008

  3. Draft 1A: Study objective • Measure intra- and inter reader bias and variability on phantom lesions for: • Uni-dimensional size measurement • Semi-automated 3D volumetric measure • Compare with fully automated algorithm? Not going to size for specific effect or significance but just report as pilot N Petrick RSNA QIBA Phantom Group November 13, 2008

  4. Draft 1A: Nodule/scan dataset • Nodules (10 attached nodules) • -10 & +100HU • 10, 20 mm spheres • 10 mm ovoid, lobulated, spiculated • Scanner • Philips 16 slice • Exposure (120 kVp): • 100 mAs • Slice thickness (50% overlap) • 0.75 & 5.0 mm slices • Recon kernel • Standard/medium (Still on table: Detail/Lung kernel) • Pitch • 1.2 • 2 repeat scans • 40 segmentations in set Okay 100 mAs okay 0.75 mm slices okay Okay N Petrick RSNA QIBA Phantom Group November 13, 2008

  5. Draft 1A: Study Protocol • Reader: • 6 RadPharm radiologists • Software: • In-house review software (Siemens?) • Semi-automated 3D volume software • Uni-dimensional measure (RESIST) • Which fully automated software? Need to determine this? Wendy will visit RadPharm and provide more info next week. N Petrick RSNA QIBA Phantom Group November 13, 2008

  6. Draft 1A: Study Protocol • Reading session: • Readers read all cases in 2 different reading session • Random ordering • One-dimensional measure • Semi-automated segmentation • Session separated by 3 week? • Include duplicate cases within each read session (1/3-1/2 of cases for intra-reader estimates) • Any time restrictions? • Probably not • Any specific instructions? • Probably not N Petrick RSNA QIBA Phantom Group November 13, 2008

  7. Draft 1A: Analysis Okay • Estimate intra- and inter-reader variability in the different volume estimate • Estimate bias from known truth • Estimate variability • Compare the bias and variability with the different methods N Petrick RSNA QIBA Phantom Group November 13, 2008

  8. Draft 1A: Outstanding issues • Objective-Okay • This is pilot, no sizing will be done • May want to at least look at this to see if we have a reasonable study design • Data collection: Okay • +100 HU (all 1A scanner settings) • Acquired: 10 mm & 20 mm sphere, ovoid, spic, lob • -10 HU (all 1A scanner settings) • Acquired: 10 mm & 20 mm sphere • Missing: 10 mm ovoid, spic, lob (Est: 12/01/08) • 10 mm aspherics okay • 100 mAs okay N Petrick RSNA QIBA Phantom Group November 13, 2008

  9. Draft 1A: Outstanding issues • Readers-Okay • 6 okay (base on expected effect size?) • Software-Open source option is available to use • Need to finalize which software • Contact Bob Ford to discuss • Study Issues • GUI • AVT designed interface? • Standard PACs interface? • How will nodule locations be provided to readers? • Full scans with nodule centers • Extracted ROIs • Can cases be directly uploading into PACs? • How to randomize cases during reading sessions • Data format for segmentations/measurements • Truth/scoring format • ROIs or full scans with lesion marked N Petrick RSNA QIBA Phantom Group November 13, 2008

  10. Draft 1A: Pilot Study • Study protocol • 9 nodules for segmentation • 2 slice thickness • 10 mm -10 HU, sphere, spiculated • 10 mm, +100 HU, lob., ovoid • 20 mm, +100 HU, sphere • 3 nodules with each segm. method • 2 readers • Timeframe • Needs to be determined N Petrick RSNA QIBA Phantom Group November 13, 2008

  11. Draft 1A: Outstanding issues • Statistical • Can we measure intra-reader variance with only 2-4 repeat reads? • What effect size can we distinguish? • Again, may want to explore but this study will only measure as in a pilot N Petrick RSNA QIBA Phantom Group November 13, 2008

  12. Draft 1A: Outstanding issues • Other issues • Need to define QIBA publication policy • Determine research team makeup • Lisa Kinnard & Marios Gavrielides from FDA lab • Other Issues N Petrick RSNA QIBA Phantom Group November 13, 2008

  13. Draft 1A: Submissions • Conferences • ASCO • 5/29-6/2/09 Orlando • Abstract Deadline: 1/6/09 • RSNA • End Nov, 2009, Chicago • Abstract Deadline: 4/15/09 • Journal • NEJM! • Radiology • Oncology journals? N Petrick RSNA QIBA Phantom Group November 13, 2008

  14. Action Items • Rick Avila to follow-up with caBIG AVT group • Rick Avila to lead effort of Lesion Ground Truth subgroup • Reporting Mechanism to be discussed at later date N Petrick RSNA QIBA Phantom Group November 13, 2008

  15. Work Items and workgroup • ?? N Petrick RSNA QIBA Phantom Group November 13, 2008

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