Project Summary / Abstract Tumor imaging quantification is critical for cancer diagnosis, staging, and treatment evaluation, and multi-detector CT (MDCT) is the clinical imaging modality commonly used for patients diagnosed with hepatic malignancy because of its relatively low cost and wide availability. Conventional tumor quantification using either linear or volumetric measurement has demonstrated significant limitations in the evaluation of malignant liver tumors such as for hepatocellular carcinoma (HCC) when being treated with targeted antiangiogenic therapies or locoregional therapies because changes in overall tumor size do not necessarily reflect tumor response to therapy. This leads to an unmet clinical demand to develop a functional tumor quantification biomarker (QIB), for effective and accurate assessment of treatment response for liver cancer patients. In the phase II project, we developed a hepatic tumor viability (HTV) QIB for automated quantification of tumor viability of HCC using contrast-enhanced multi- phase hepatic MDCT images and transferred the HTV technology to IQ Medical Imaging’s Advanced Tumor Quantification Imaging (ATIQ) Software as Medical Device (SaMD) with an FDA Compliant Quality Management System (QMS), and evaluated it using MDCT datasets of 200 patients with advanced HCC treated with antiangiogenic therapies and trans-arterial chemoembolization (TACE) therapies collected at MGH Cancer Center. In the CRP project, we propose three specific aims: (1)FDA 510(k) clearance and post-market surveillance of ATIQ SaMD: We will develop an FDA 510(k) strategy, prepare submission materials and complete the FDA 510(k) submission using expert consultants; Obtaining FDA 510(k) clearance with submission support; and implement a post-market surveillance strategy. (2) Development of commercialization strategy for ATIQ: we will perform an in-depth market research analysis for the US and global market with expert consultants; and develop a comprehensive business plan addressing funding and commercialization options; and (3) Development of Intellectual Property (IP) and Licensing Strategy for ATIQ: employing consultants with licensing expertise, we will complete the IP licensing agreement with Partners HealthCare related to the original algorithms and software to be used in ATIQ; and develop a comprehensive IP strategy for licensing and protection of ATIQ technologies. Successful completion of the CRP will deliver this clinically impactful HTV technology as an FDA approved ATIQ SaMD providing an effective and accurate tumor quantification tool compared to conventional size-based methods for reliable assessment of tumor progression and treatment response for patients with HCC.