May 19-20, 2009

Quantitation, both single point and longitudinal*, of tumor metabolism via FDG-PET/CT that can be used practically and efficiently as a biomarker. This biomarker shall be of known precision and accuracy when used in single- and multi-center, multi-vendor clinical trials and meta-analyses, enhancing its potential for use in patient care and qualification for use in clinical studies of pathophysiology and therapeutic interventions. *measuring change over time (e.g., pre- and post- treatment in a clinical trial of an investigational agent or for refinement of patient care during a course of therapy.

Can find in the DICOM header reliable data required for SUV calculation  Short-term: single standard stack, multiple vendors  Mid-term: validate receiving workstations with vendor- specific stack with header and standardized SUV truth values (sample data)  Long-term: raw data--validate image generation beyond acquisition point AND receiving workstation

 Completed description of rationale, limitations, and proposed solutions for patient weight, height, injected activity, blood glucose, time, fasting time, hydration, physical activity, FDG uptake time (based in part on NCI guidelines)  General proposal is to ◦ Improve and standardize measurements affecting SUV quantification (e.g. time, weight) ◦ Embed results in public DICOM tags of patient study ◦ Display results on viewing and analysis workstations (glucose, FDG uptake period)

Can create, store, retrieve FDG-PET/CT images  Stage 1: Manually record the SW version number and flag the impact on quantitation  Stage 2: Record all SW Version numbers in DICOM header

 Completed description of rationale, limitations, and proposed solutions for CT and PET calibration and quality control  Propose that vendors make QC results (only pass/fail/warning) and calibration results (mean, variance) readily accessible as external files or ideally incorporated in the public DICOM tags of each patient study

Claim: Can create, store and retrieve markups of SUV measurements in accordance with a standard definition for RoI that provides a known balance between precision and accuracy Precursor: Survey of vendor to assess ROI tools and algorithms currently available to determine whether current methodologies can be defined on current systems and make recommendations to vendors for ROI in the future.

 Improve the max-pixel method by additionally reporting the mean of a pre- defined cluster of neighboring pixels  For a given pixel cluster, use for calculated a mean value (equivalent to smoothing the image with a kernel based on this luster shape and size and reporting the maximum pixel value within a broad user-defined region)

 Anatomically based ROIs to provide objective means of measuring FDG uptake within larger volumes