Our long-term goal is to obtain FDA 510(k) clearance and to bring to market LiverScope®, a low cost, easy-to-use, table-top, point-of-care device for use in research and clinical settings to assess quantitative biomarkers of nonalcoholic fatty liver disease (NAFLD). LiverScope® uses novel, noise-free, advanced magnetic resonance (MR)-based technology, requires no room shielding, and can be sited in a standard clinic room for point-of-care access or can be operated in a small van for mobile diagnostic delivery. Our initial focus is on the estimation of proton-density fat fraction (PDFF), a standardized MRI-based biomarker of hepatic steatosis. Our immediate goal (and the focus of this application) is to perform Phase 1 studies in phantoms and humans to verify that PDFF estimated by LiverScope® (LiverScope®-PDFF) meets conformance standards developed by the Quantitative Imaging Biomarkers Alliance. The primary specific aims of this Phase 1 proposal are to verify that PDFF estimated by LiverScope® agrees with ground-truth phantom PDFF values (Aim 1) and is repeatable and reproducible in humans (Aim 2). Success full demonstration of quantitative milestones of success in Aims 1 and 2 will support the design, planning, and execution of a future, larger, multi-center Phase 2 proposal to obtain FDA 510(k) clearance. Likelihood of success is leveraged by prior conversations with FDA, patents to protect Livivos' intellectual property, and supportive preliminary data. After LiverScopeï¢ is FDA cleared to estimate PDFF, we will investigate its capability to assess other potential biomarkers of NAFLD, such as T1 relaxation, T2 relaxation, and diffusivity (proposed biomarkers of liver disease activity and damage).The innovation of the proposed work resides in the creation of novel technology to estimate MR-based quantitative biomarkers of NAFLD at low cost and in point-of-care settings while maintaining the accuracy and precision of full-size MRI scanners. The clinical significance of the proposed work is that widespread implementation of this technology will enable earlier diagnosis, more timely referral to specialists, and greater access to monitoring of NAFLD. If the goals of this Phase 1 SBIR proposal are met, and if a follow-on comprehensive Phase 2 SBIR studies result in FDA 510(k)clearance of LiverScopeï¢ for PDFF estimation, deployment in primary care, rural, underserved, and third-world communities will be possible. Future expansions of LiverScopeï¢ capability to include assessment of liver disease activity and damage could be transformational to the medical care of patients with known or suspected NAFLD. This technology could support point-of-care and mobile clinical application in numerous contexts of use, including early detection, diagnosis, staging, monitoring, and treatment response assessment; early intervention to prevent downstream hepatic and extra hepatic complications of NAFLD; large-scale epidemiology studies to better understand the prevalence and genetics NAFLD; and more efficient screening, enrollment, and execution of clinical trials to accelerate drug discovery.
Public Health Relevance Statement: Project narrative: Livivos aims to improve care for liver disease by introducing LiverScope®, a low-cost, table-top device that applies advanced magnetic resonance-based technology to assist in the diagnosis and management of liver disease. The introduction of Livivos' technology will have a significant impact on early diagnosis, risk stratification, and management of therapies for liver disease. LiverScope® requires no room shielding which allows it to be sited in a standard clinic room for point-of-care access, or in a small van for mobile delivery of diagnostic services.
Project Terms: Clinical Research, Clinical Study, Clinical Trials, Communities, Diagnosis, Diagnostic Services, diagnosis service, Fatty acid glycerol esters, Fats, Fatty Liver, Liver Steatosis, hepatic steatosis, hepatosteatosis, Future, Patient Care, Patient Care Delivery, Goals, Health Services Accessibility, Access to Care, access to health services, access to services, access to treatment, accessibility to health services, availability of services, care access, health service access, health services availability, service availability, treatment access, Human, Modern Man, Liver diseases, Hepatic Disorder, hepatic disease, hepatopathy, liver disorder, Magnetic Resonance Imaging, MR Imaging, MR Tomography, MRI, MRIs, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, NMR Imaging, NMR Tomography, Nuclear Magnetic Resonance Imaging, Zeugmatography, Noise, North America, Patents, Legal patent, pilot study, Pilot Projects, Primary Care, Primary Healthcare, Primary Health Care, H+ element, Hydrogen Ions, Protons, General Radiology, Radiology, Radiology Specialty, Recommendation, Relaxation, Research, Societies, Standardization, Technology, Testing, Time, Work, Specialist, Caring, base, density, improved, Hepatic, Site, Clinical, Diffuse, Phase, Medical, Sample Size, Early Intervention, Intellectual Property, Genetic, Staging, Diagnostic, Clinic, early detection, Early Diagnosis, success, Intercept, novel, Agreement, novel technologies, new technology, Devices, Epidemiologic Research, Epidemiologic Studies, Epidemiological Studies, Epidemiology Research, epidemiologic investigation, epidemiology study, Modeling, Magnetic Resonance, drug discovery, preventing, prevent, Data, Reproducibility, Enrollment, enroll, Extrahepatic, Small Business Innovation Research Grant, SBIR, Small Business Innovation Research, technology validation, technology implementation, Monitor, point of care, cost, design, designing, human study, Prevalence, innovation, innovate, innovative, clinically significant, clinical significance, clinical application, clinical applicability, treatment response, response to therapy, response to treatment, therapeutic response, therapy response, Biological Markers, bio-markers, biologic marker, biomarker, phase 1 study, Phase I Study, phase 2 study, phase II study, Secure, screening, quantitative imaging, imaging biomarker, imaging marker, imaging-based biological marker, imaging-based biomarker, imaging-based marker, potential biomarker, potential biological marker, risk stratification, stratify risk, rural underserved, rural under served, non-alcoholic fatty liver disease, NAFLD, non-alcohol fatty liver disease, non-alcoholic liver disease, nonalcoholic fatty liver disease, disease diagnostic
