TY - JOUR T1 - Successful implementation of near-real-time central review of FDG PET/CT examinations for differentiating responders from non-responders in a Phase II multi-center combined modality therapy adaptive clinical trial JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 359 LP - 359 VL - 57 IS - supplement 2 AU - Nathan Hall AU - Jun Zhang AU - David Poon AU - Michael Knopp Y1 - 2016/05/01 UR - http://jnm.snmjournals.org/content/57/supplement_2/359.abstract N2 - 359Objectives Successful utilization and optimization of PET/CT as a biomarker in multi-center clinical trials requires extremely tight adherence to data acquisition criteria and stringent quality control compliance. A strong commitment by the investigators to education of the imaging staff on protocol specific acquisition and data transfer criteria is an absolute necessity when using FDG PET/CT as a quantitative methodology to make real-time decisions within a clinical trial framework. The successful integration of PET/CT technology as a biomarker for near real-time read necessary adaptive clinical trials requires robust and reproducible data collection and de-identification of data sets combined with timely transmittal/submission of data to the imaging core lab (ICL). Overall success in this design also requires that the ICL coordinate and facilitate near real-time clinical interpretation/assessment of response based on PET/CT scan data with subsequent transmittal of results back to the treating site so that the appropriate clinical trial decisions can be made. We present here the results of successful integration of near real-time centralized review of clinical FDG PET/CT scan data, coordinated by an ICL, for use in determining the treatment pathway in an adaptive multi-center clinical trial for esophageal cancer therapy.Methods PET/CT data sets for a randomized Phase II trial of PET/CT scan-directed combined modality therapy in esophageal cancer were collected by the ICL at The Ohio State University Wexner Medical Center. After evaluation for protocol compliance the ICL organized centralized review of these studies for comparison of primary tumor SUVmax between baseline and post-induction PET/CT scans in order to differentiate responders from non-responders based on a pre-defined SUVmax percent change.Results Imaging data was received on a total of 256 subjects for this trial. 28 patients were deemed ineligible for inclusion based on study criteria. A total of 454 PET/CT studies were received by the ICL. Of the 228 patients enrolled, 178 (78%) of these patients had imaging data reviewed and results back to the clinical provider at the local site within two days after the post induction PET/CT scan acquisition and 216 (95%) of these patient had reviewed results back to the local site within three days of the post-induction PET/CT acquisition as organized through the ICL.Conclusions Our results demonstrate the feasibility of acquiring robust and reproducible quantitative PET/CT imaging results by an ICL organized central review. This proved successful for use in an adaptive clinical trial for a near real-time quantitative assessment of PET/CT imaging data for determining the adaptive trial response criteria. The ICL was able to organize key elements, including adherence to a strict acquisition and data transmittal QA program, such that patients will be compliant and subsequently follow on the successive clinical trial elements. ER -