JSM Preliminary Online Program
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Activity Number: 233
Type: Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304527
Title: Guidelines for the Analysis of FDG-PET Imaging Biomarkers
Author(s): Patricia English*+ and David Raunig and Santos Carvajal-Gonzalez and Yanwei Zhang
Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
Address: 10555 Science Center Drive, San Diego, CA, 92121,
Keywords: Analysis ; Imaging ; Biomarkers ; FDG-PET ; Oncology ; Proof of Mechanism
Abstract:

PET images provide fit-for-purpose biomarkers that contribute to clinical trial study design in many therapeutic areas and have been used extensively in oncology and neurosciences. Fluorine-18 labeled 2-deoxy-D-glucose (FDG) is a glucose analog that is taken up in cells through the same glycolysis pathways as glucose and can provide biomarker data that is closely linked to changes in glucose metabolism of many cancers. In oncology clinical trials (CT), FDG-PET can provide critical assessments of a drug's ability to affect a desired metabolic mechanism. The multifaceted issues associated with cancer studies and the typically small study sizes for Proof of Mechanism present formidable statistical challenges. We will discuss the analysis of the SUV, study design considerations for patients, lesions, baseline thresholds, and variability, and analysis models for FDG-PET in CTs, including POM.

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Revised September, 2008