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Tumor Imaging Metrics Core

In these scans completed for trial 009-02, the right liver lesion measured 21.7 X 14.2 mm with a SUV of 12.74 on baseline (left). On follow-up 1, the right liver lesion measured 9.8 X 7.8 mm and was no longer FDG avid (right).

Under the direction of Annick Van den Abbeele, MD (DFCI) and Gordon Harris, PhD (MGH), the Tumor Imaging Metrics Core (TIMC) provides objective assessment of imaging response to treatments being evaluated through approved cancer clinical trials across the five DF/HCC hospitals (BIDMC, BWH, CHB, DFCI, MGH) using independent tumor measurements of radiological scans (CT, MR and PET).  With convenient locations at BWH, DFCI and MGH, the TIMC produces high-quality data with fast turnaround time.

All major radiological assessment criteria are supported, including; RECIST (1.0 and 1.1), WHO, IWRC, Cheson, SUV, Choi, 3D Volume and irRC. For each subject, target and non-target lesions are selected according to the assessment criteria guidelines and are tracked longitudinally. Scans to be measured are transferred to the central core facility via DICOM imaging network. Quantitative analyses of imaging studies are performed on a variety of modality-specific workstations. After scans are analyzed, the measurement results are reviewed and finalized by Harvard faculty radiologists and nuclear medicine physicians. Results are stored in a custom-designed database on a secure website and are viewable online by authorized trial staff (www.tumormetrics.org). Summary statistics for the trial are presented as well as individual patient measurements. Requests for scan analysis can be ordered online.

The quantitative measurements provided by the facility are used to determine tumor response to treatment and, ultimately, guide patient care. To date, the TIMC has analyzed more than 25,000 scans for 600 clinical trials, nine Research Programs and five member institutions. Project examples include:

Phase I Study of Lapatinib in Combination with Radiation Therapy in Patients with Brain Metastases from Her2-Positive Breast Cancer (06-356, PI: Nancy Lin, MD (DFCI)). The Core provided RECIST, WHO, and volumetric measurements of brain metastases for the trial to assess the efficacy of Lapatinib following whole brain radiation therapy (WBRT). Very high quality response data was collected in patients across multiple institutions, including volumetric, linear and bi-dimensional measurements. The bi-dimensional analysis allowed for comparison to historical controls, and having both volumetric and bi-dimensional measurements created a rich database in conjunction with other trial endpoints (quality of life, neurological symptoms, overall survival) to help address a major question in the field: how best to assess brain metastases for response and what types of response are clinically meaningful.

The high-dose aldesleukin (IL-2) "SELECT" Phase II trial: A trial designed to prospectively validate predictive models of response to high dose IL-2 treatment in patients with metastatic renal cell carcinoma (06-149, PI: David McDermott, MD (BIDMC)). The Core provided WHO measurement from whole-body CT and MR scans for the trial to assess response to high-dose aldesleukin in metastatic renal cell carcinoma. The Phase II study was conducted at BIDMC, Indiana University, City of Hope, Chiles Cancer Center, Roswell Park Cancer Institute, University of California Los Angeles, Dartmouth Hitchcock Medical Center, University of Pittsburgh Cancer Institute, Loyola University Medical Center, Wayne State University and University of Cincinnati. The Core served as the independent, central review for all sites. Quality bi-directional measurements were collected for patients across multiple institutions and emphasized the importance of standardized, independent imaging review in oncology clinical trials.

Phase II Study of everolimus in combination with rituximab for relapsed/refractory diffuse large B cell lymphoma (09-002, PI: Jeremy Abramsom, MD (MGH)). The Core provided Cheson measurements of whole-body CT scans and SUV analysis of whole-body PET scans to assess efficacy of everolimus in combination with rituximab for diffuse large B cell lymphoma. The Phase II study was conducted at MGH, BIDMC, and DFCI. The TIMC matched bi-directional CT measurements and SUV values to provide a more thorough understanding of the relationship between structural and functional treatment response.