Imaging plays a major and growing role in non-invasively assessing cancer biology both pre-clinically 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 targets are present, whether the target 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 Kimmell Cancer Center at JHU. Qualitative imaging is now being complemented by sophisticated quantitative approaches. To assure access to advanced imaging technologies including quantitative PET, MRl, and CT the Imaging Response Assessment Laboratory (IRAT) has been established within the SKCC. The IRAT was first established as a competitive NCI supplement to the CCSG, and is now being transitioned to a Core service available to cancer center investigators. Services of the IFWVT available to SKCC 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 RECIST 1.1, 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, g) Regulatory guidance on radiation exposure and molecular imaging agents, and h) Improving collaborations among cancer center investigators and imaging specialists in quantitative imaging. Future plans include assuring computing and software platforms are updated to continue to provide robust quantitative analyses of single and multimodal 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 JHU and in collaboration with other institutions. Appropriate quantitative imaging should benefit clinical cancer therapy trials of all phases and should accelerate translational cancer research. Lay: For cancers to be treated effectively and for new treatments to be tested and evaluated, precise non-invasive quantitative imaging of the location, size and biological characteristics of the cancers is essential. The IFJAT core uses PET, MRl, CT and other tools to evaluate tumors, determine if they are likely to respond to treatment and quantifies quickly and accurately whether the tumors are suitable for a given treatment, are responding to treatment or are failing to respond
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