Abstract

20571 Background: Reliable tracking of lesion size and/or function over time is essential in clinical trials that use radiological measurements as surrogate endpoints. Current clinical practice typically does not provide the standardized measurements required for patients enrolled in clincal trials. It is difficult to maintain consistancy and reproducibility with the ad hoc methods used clinically to obtain tumor measurements. Additionally, these methods are also time-consuming for trial staff and radiologists. The Dana-Farber/Harvard Cancer Center established the Tumor Imaging Metrics Core (TIMC) in order to deliver standardized tumor measurement services to DF/HCC clinical trials in an efficient and cost-effective manner. Methods: The TIMC provides accurate analysis of CT, MRI and PET imaging studies for clinical trials. After the scans are analyzed by TIMC’s staff, the measurement results are then reviewed and finalized by Harvard faculty radiologists and nuclear medicine physicians. The results are stored in an SQL database and posted on TIMC’s secure website which is accessible to authorized trial staff and physicians. TIMC also provides protocol consultation to investigators planning clinical trials that require imaging as a primary or secondary surrogate endpoint. Results: Since TIMC’s beginning in 2004, over 2,500 scans have been reviewed with trial volume steadily increasing. Currently TIMC is managing tumor assessment in 146 oncology trials from 10 disease programs. An in-house study was done to determine inter-rater reliability between Image Analysts, with a reliability coefficient of 0.94. Clinical Trials’ staff have reported that TIMC’s service is fast, accurate, and generally improves reliability of tumor response measurement in clinical trials. Conclusions: TIMC addresses an outstanding need for efficient and consistent delivery of standardized radiologic measurements for clinical trials in a multi-institutional comprehensive cancer center. Its unique blend of expertise, efficient sharing of resources, advanced technology, and service, TIMC has become strategically indispensable to the Cancer Center and serves as a model for the future development of similar cores. No significant financial relationships to disclose.

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