Qualification of FDG PET/CT as an oncologic biomarker: A methodology demonstration for lymphoma

1046 Learning Objectives 1. To be aware of the methodological approach implemented in the Oncology Biomarker Qualification Initiative, a broad, national academia-industry partnership effort to qualify PET/CT imaging as a potential biomarker. 2. To review the organizational and technical challenges of such an effort. 3. To update about the current status. The stated goal of the OBQI is to validate [and subsequently qualify] biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients. In 2007, a project plan was conceived by investigators from CALGB to examine the utility and predictive value of FDG-PET/CT in assessing response to chemotherapy in lymphoma in a prospective setting. The trial has been funded utilizing a public private partnership structure under the sponsorship of the FNIH and is still in progress. To achieve the goal the following specific aims are established for this effort: 1. Establish the correlation between quantitative imaging biomarker and clinical endpoints to prove surrogacy as a predictive marker. 2. Show that the new biomarker can detect futility, that is, progressive disease events, sooner than standard biomarker. 3. Provide contributory evidence that may be utilized to satisfy outcome studies needed to approve and/or clear imaging tests and agents. 4. Provide contributory evidence that may be utilized to satisfy requirements for coverage decisions leading to reimbursement for longitudinal quantitation. 5. Show that FDG-PET is a quantitative measure of cellular metabolism. Research Support The Oncology Biomarker Qualification Initiative (OBQI) is a FDA/NCI/CMS effort organized and supported via the Foundation of the National Instititues of Health (FNIH)