PROJECT SUMMARY/ABSTRACT Imaging has become the leading diagnostic procedure in early and advanced clinical trials of cancer therapeutics, which provides key information as to whether lesions are responding to the therapy. Qualitative imaging is now being complemented by sophisticated quantitative approaches, such as Machine and Deep Learning and Radiomics. To ensure access to advanced imaging technologies, including quantitative PET, MRI and CT, the Imaging Response Assessment and Biopsy Services Team (IRAT) Shared Resource (SR) continues to provide services to Sidney Kimmel Comprehensive Cancer Center (SKCCC) investigators, including: 1) consultation and guidance on the proper choice, design and use of imaging studies in clinical trials; 2) expert reviews of clinical protocols to assure that the imaging protocol and analysis plans are appropriate for the chosen task; 3) state-of-the-art prompt and accurate assessment of tumor response using standardized anatomic and metabolic response criteria, including RECIST 1.1, IrRECIST, PERCIST 1.0 and other imaging-defined response metrics; 4) image archival, anonymization and data import/export for trials; 5) development and integration of a new research biopsy management service, which assists and monitors research biopsies to make sure they are performed according to protocol, guaranteeing that the appropriate core samples are acquired for study compliance; 5) developing documents, protocols and forms to assist in studies performed at one or multiple sites; 6) regulatory guidance on radiation exposure and molecular imaging agents; 7) assisting in the development of nontraditional imaging metrics for response assessment, including participation in ACRIN and ECOG trials; 8) improving collaborations among SKCCC investigators and imaging specialists in quantitative imaging; and 9) providing novel deep learning and radiomic metrics for detection, classification and monitoring treatment response. Future plans include introducing these new and advanced computing and software platforms for robust quantitative analyses of single and multimodality imaging studies of cancer treatment response. The IRAT SR's 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 and in collaboration with other institutions. The appropriate quantitative imaging methodology will benefit clinical cancer therapy trials at all phases and accelerate translational cancer research. The IRAT SR provides critical services using radiological imaging methods, such as PET, MRI and CT, and by acquiring tissue samples to help evaluate tumors and determine the potential of response to different treatments. SKCCC Managed Shared Resource Reporting Period: January 1, 2020 to December 31, 2020