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.
Public Health Relevance Statement: Project Narrative Theranostics combines molecular targeted diagnostic and therapeutic radionuclides for imaging and therapy. AIQ Solutions will build a dedicated AI-powered theranostics software -TRAQinform Theranostics- to provide objective and actionable information predicting and summarizing theranostic patient response to meet the currently unmet need for theranostic patient management, not addressed by any existing commercial products.
Project Terms: Algorithms; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; Clinical Research; Clinical Study; Clinical Trials; Decision Making; Dedications; Lutetium; Manuals; Marketing; Discipline of Nuclear Medicine; Atomic Medicine; Nuclear Medicine; Radiology / Radiation Biology / Nuclear Medicine; Legal patent; Patents; Patients; Physicians; Probability; Prostatic Neoplasms; Prostate Neoplasms; Prostate Tumor; Prostatic Neoplasia; Quality of life; QOL; Radionuclide Imaging; Gamma Camera Imaging; Radioisotope Scanning; Scintigraphy; radionuclide imaging/scanning; radionuclide scanning; Research; Research Personnel; Investigators; Researchers; ROC Curve; ROC Analyses; receiver operating characteristic analyses; receiver operating characteristic curve; Computer software; Software; Software Tools; Computer Software Tools; software toolkit; Testing; Time; rho; Measures; Health Costs; Healthcare Costs; Health Care Costs; Organ; improved; Image Analyses; image evaluation; image interpretation; Image Analysis; therapeutic radionuclide; Radionuclide therapy; Area; Clinical; Phase; Medical; Peptide Receptor; Evaluation; Lesion; Individual; participant recruitment; Patient Recruitments; Patient Selection; uptake; Medical Oncologist; tool; Disseminated Malignant Neoplasm; Metastatic Cancer; Metastatic Malignant Neoplasm; Diagnostic; Malignant neoplasm of prostate; Malignant Tumor of the Prostate; Malignant prostatic tumor; Prostate CA; Prostate Cancer; Prostate malignancy; Prostatic Cancer; Life; System; Radiation Dose Unit; Radiation Dose; Performance; radiotracer; radiolabel; radiolabels; receptor; Receptor Protein; receptor expression; dosimetry; Toxic effect; Toxicities; novel; Modality; Positioning Attribute; Position; Early identification; Modeling; response; image-based method; imaging method; imaging modality; Effectiveness; FOLH1 gene; FOLH; FOLH1; Folate Hydrolase 1; GCP2; Glutamate Carboxypeptidase II; N-Acetylated Alpha-Linked Acidic Dipeptidase 1; NAALAD1; NAALADase I; PSM; PSMA; Prostate-Specific Membrane Antigen; Dose; Data; Detection; Molecular Target; Prediction of Response to Therapy; predict therapeutic response; predict therapy response; predict treatment response; therapy prediction; treatment prediction; treatment response prediction; Radiation Oncologist; Reader; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Process; Tracer; Development; developmental; molecular imaging; molecule imaging; PET/CT scan; PET/CT; positron emission computed tomography; Image; imaging; Output; cost; designing; design; intervention efficacy; therapeutic efficacy; therapy efficacy; Treatment Efficacy; Clinical effectiveness; Outcome; prospective; clinical relevance; clinically relevant; usability; commercialization; tumor; spatiotemporal; FDA approved; standard of care; response to therapy; response to treatment; therapeutic response; therapy response; treatment response; clinical decision-making; theranostics; castrate resistant PCa; castrate resistant prostate cancer; castration resistant CaP; castration resistant PCa; castration resistant prostate cancer; personalization of treatment; personalized therapy; personalized treatment; personalized medicine; therapeutic toxicity; therapy associated toxicity; therapy related toxicity; therapy toxicity; treatment toxicity; treatment-associated toxicity; Treatment-related toxicity; patient specific response; responsive patient; patient response; Patient imaging; prostatic lesions; prostate lesions; prognosis model; prognostic model
