1. FDG PET/CT

2. FDG-PET/CT Technical Committee Breakout 081204 Regular meetings of working groups with RSNA administrative support and milestones for delivery during 2009 Regular “SNM cross-over” each TC tcon Communication of recommendations to vendors with reasonable expectation of implementation timeframe Expanded list of co-variates New Profiles QC Export standards (RIC, cross-check, Bresolin) De-identification irrespective of medium (DICOM cross-check) Trials and service apps (public & private label & access) Performance elements and standards (Yap)

3. Monitoring Rx Benefit = Individualized Medicine Convergence of Biomarkers and Diagnostics H/o Commercial Dx Individuals - thresholds Categorical, staging Workflow/# studies Binary – choice of Rx Biomarkers become Dx Population means, s Continuous, quantitative Automation/bias Longitudinal – monitor Rx Quantifying the effects of drugs in development may beg access to biomarkers as diagnostics

4. Quantitative Imaging Are we there yet?

5. Tumor Tracking Application Simplifying cancer patient management Compare, analyze, and track tumor progression with up to six sequential PET/CT studies SUV-based semi - automatic tumor segmentation Measurement of changes in tumor volume and metabolic activity Export tables and graphs or 3D contours

6. Reality Today with Siemens syngo TrueD Visualization 3 Time Points Display MIP Triangulation Gating Support Quantification 2D/3D Iso-Contouring 1-Click SUVmax RT Structure Export Trending Trending Charts VOI Propagation Deformable Registration Innovation is in our genes. 6 Siemens Medical Solutions Molecular Imaging Longitudinal Quantification in Hybrid Imaging

7. 1.Automatic co-registration of multiple studies 2.Automatic segmentation of VOI based on % or SUV 3.CT or PET-guided lesion definition Timepoint 3Timepoint 2Timepoint 1

8. Compare tumors across any number of time points for multiple modalities Gradient-based PET segmentation for more accurate tumor volumes and statistics Export statistics for sharing with referring physicians Accurate registration allows the same region to be compared Difference images highlight variable tumor response Therapy Response Assessment www.mimvista.com

9. Automatically register serial studies for longitudinal accuracy Automatically segment and propagate ROIs for efficiency and robustness Quantify serial changes with a comprehensive set of metrics (SUV, Total Lesion Glycolysis, Functional Volume) and present in tabulated and graphical form Export tabulated data for easy utilization in 3 rd party analysis routines GE PET VCAR…Powerful Longitudinal Analysis

10. FDG-PET/CT Technical Committee Aim The aim of the QIBA FDG-PET/CT Technical Committee is to foster adoption of pragmatic and cost-effective standards for accurate and reproducible quantitation of tumor metabolism via longitudinal measures by FDG-PET/CT, with clinical relevance and known sigma.

11. System and protocol character- ization SUV quantitation and ROI computation Covariates, data/version tracking, verification Digital referenc eobject Serial and multi-center SUV measurements SUV change analysis Profile claims Profile detail specification Precursor specifications Pattern for PET SUV Measurements as a Biomarker PET SUVs as a target- and mechanism-specific biomarker of response A.Drug development; Business decisions B.Drug development; Regulatory decisions C.Patient monitoring; Individualization of therapy Patient variability and effect size Uses:

12. FDG-PETCT Technical Committee Subcommittee Topics [chair] Quantitation Computation [David Clunie] Digital Reference Objects – Images [Paul Kinahan] Covariates rationale (Normalization) [Yuying Hwang] RoI Definition (and then Adoption) [Tim Turkington] Subcommittee slides deleted for sake of file size need updating to current status

13. Milestones Horizon/PET-CT Beyond RSNA’08 Quantitation Computation Documentation of terms RSNA ‘08 RSNA ‘09 RSNA ’10 and on Feasibility H, M, L Value H, M, L Priority H, M, L High Interoperability of Results Encoding Image Quality Metrics Calibration Phantoms Characterization Lo, Hi rads RoI Definition* Dynamic Range lesion size** High Medium High Quick Hits High *Adoption 2010-11, Defined in 2008 **Ideal Phantom 2010- 11 Current phantom by 2008

14. Quantitative Imaging Biomarker Alliance FDG- PET/CT Working Group Report RSNA News September 2008, Vol 18, No 9 Molecular Imaging and Biology 1536-1632 (Print) 1860-2002 (Online) Hallett WA, Maguire RP, McCarthy TJ, Schmidt ME, Young H. Considerations for generic oncology FDG-PET/CT protocol preparation in drug development. IDrugs, 2007 Nov; 10(11):791-6.

15. FDG PET/CT