Imaging plays a major and growing role in noninvasively assessing cancer biology, preclinically and in clinical translational studies. Imaging is now being used to personalize therapies in clinical practice. In early and advanced clinical trials of cancer therapeutics, imaging can provide key information on the mechanisms of action of the treatment, including whether target lesions are present, whether the target lesion is ?hit? by the therapy, whether the cancer is responding and if tumor progression has occurred. Elements of such measurements are an important part of many studies involving cancer therapy conducted at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). Qualitative imaging is now being complemented by sophisticated quantitative approaches. To assure access to advanced imaging technologies, including quantitative PET, MRI and CT, the Imaging Response Assessment (IRAT) Core was established within the SKCCC. Services of the IRAT available to SKCCC investigators include: a) consultation and guidance on the proper choice, design and use of imaging studies in clinical trials; b) expert reviews of clinical protocols to assure that the imaging protocol and analysis plans are appropriate for the chosen task; c) state-of-the-art prompt and accurate assessment of tumor response using standardized anatomic and metabolic response criteria, including Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and PET Response Criteria in Solid Tumors (PERCIST) 1.0; d) image archival, anonymization and data import/export; e) developing documents, protocols and forms to assist in studies performed at one or multiple sites; f) regulatory guidance on radiation exposure and molecular imaging agents; g) assisting in development of nontraditional imaging metrics for response assessment, including participation in ACRIN and ECOG trials; and h) improving collaborations among SKCCC investigators and imaging specialists in quantitative imaging. Future plans include new and advanced computing and software platforms to continue to provide robust quantitative analyses of single and multimodality imaging studies of cancer treatment response with current and emerging imaging tools. IRAT input into study design and analysis is expected to lead to more appropriate, accurate and reproducible imaging in cancer therapy studies performed at The Johns Hopkins University (JHU) and in collaboration with other institutions. Appropriate quantitative imaging will benefit clinical cancer therapy trials of all phases and should accelerate translational cancer research. SKCCC Managed Core Reporting Period: Jan. 1, 2015, to Dec. 31, 2015
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