Comprehensive Assessment of Cancer Theranostics Response

Project Summary Theranostics combines molecular targeted diagnostic and therapeutic radionuclides for imaging and ther- apy in advanced malignancies, with a projected US market of more than $6.7B. Currently, metastatic castra- tion-resistant prostate cancer (mCRPC) with FDA approved lutetium-177 (177Lu)-based peptide receptor targeting radionuclide therapy (PRRT), represents the largest market. Prostate specific membrane antigen (PSMA) is the most commonly used molecular target for combined imaging and treatment of mCRPC. Recent studies have demonstrated that PSMA PET/CT has high potential to assess tumor PSMA status, treatment response assessment, and treatment-related toxicities in mCRPC. However, due to the lack of commercial image analysis software tools, the full potential of theranostic patient imaging is underutilized clinically. Currently, treating clinicians cannot fully utilize the information provided by molecular images, because manual image assessment is both laborious and subjective. Currently, there are no tools to combine and automate (1) cross-modality radiotracer uptake concordance (e.g.PSMA PET/CT vs. CT), (2) assessment of individual lesion response for all lesions, and (3) early identification of critical organ toxicity, nor can any compute all three simultaneously, quantitatively, and efficiently. Therefore, it is crucial to have a dedicated and optimized theranostics tool that provides quantitative information for all three assessments to help understand the interplay between lesion response, treatment-related toxicities, organ and lesion radiation dose estimates, target receptor expression, and the impact of each of these factors on predicting patient outcomes. To meet these challenges, AIQ Solutions proposes to develop a dedicated, AI-powered theranostics product called TRAQinform Theranostics for theranostic patient management that provides a comprehensive spatio- temporal analysis of theranostic response including: (1) quantification of target receptor status on a lesion-by- lesion basis to optimize theranostic patient selection, (2) quantification and prediction of treatment efficacy, including response of all tumor lesions, and (3) quantification and prediction of treatment-related toxicities in critical organs. Successful development of TRAQinform Theranostics will provide treating clinicians and researchers with actionable, quantitative, and clinically relevant decision-making data much earlier in the treatment process, thus improving clinical outcomes, improving quality of life and reducing therapy costs. This novel software will be integrated into AIQ’s patented, FDA 510(k)-cleared suite of treatment response assessment software.