Transcript Document
QIBA Proposed Phase 1A Project V5.0 QIBA Phantom Subgroup N Petrick RSNA QIBA Phantom Group November 13, 2008 1 Outline of proposal Modified 1A reader study Outstanding issues 2 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 fullyNotautomated going to size for specific effect or significance but just report as pilot algorithm? 3 N Petrick RSNA QIBA Phantom Group November 13, 2008 Draft 1A: Nodule/scan dataset Nodules (10 attached nodules) -10 & +100HU 10, 20 mm spheres 10 mm ovoid, lobulated, spiculated Okay Scanner Philips 16 slice Exposure (120 kVp): 100 mAs okay 100 mAs Slice thickness (50% overlap) 0.75 & 5.0 mm slices 0.75 mm slices okay Recon kernel Standard/medium (Still on table: Detail/Lung kernel) Pitch 1.2 2 repeat scans 40 segmentations in set Okay 4 N Petrick RSNA QIBA Phantom Group November 13, 2008 Draft 1A: Study Protocol Reader: 6 RadPharm radiologists Software: Need to determine this? Wendy will visit RadPharm and provide more info next week. In-house review software (Siemens?) Semi-automated 3D volume software Uni-dimensional measure (RESIST) Which fully automated software? 5 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 6 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 7 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 8 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 9 N Petrick RSNA QIBA Phantom Group November 13, 2008 Draft 1A: Pilot Study Study protocol 9 nodules for segmentation 3 nodules with each segm. method 2 readers Needs to be determined 2 slice thickness 10 mm -10 HU, sphere, spiculated 10 mm, +100 HU, lob., ovoid 20 mm, +100 HU, sphere Timeframe 10 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 11 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 12 N Petrick RSNA QIBA Phantom Group November 13, 2008 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? 13 N Petrick RSNA QIBA Phantom Group November 13, 2008 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 14 N Petrick RSNA QIBA Phantom Group November 13, 2008 Work Items and workgroup ?? 15 N Petrick RSNA QIBA Phantom Group November 13, 2008