AMRA Medical’s MRI-based Biomarkers Validated in the FNIH’s NIMBLE Study

Visceral fat, also known as Visceral Adipose Tissue (VAT), is the adipose tissue inside the abdominal cavity. VAT is a central risk factor for Non-Alcoholic Fatty Liver Disease (NAFLD), liver cirrhosis, cardiovascular disease (CVD), and type-2 diabetes (T2D). This study validates, prospectively, the precision and repeatability of AMRA Medical’s VAT biomarker for use in clinical trials.

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Approximately 25% of the general population has NAFLD and a subset is affected by the more advanced form NASH (nonalcoholic steatohepatitis). Patients with NASH are at risk of liver-related and cardiovascular morbidity. There is an unmet need to identify those patients at risk and to facilitate clinical trials using non-invasive methods.

The FNIH´s (Foundation for the National Institutes of Health) NIMBLE consortium (Non-invasive Biomarkers of Metabolic Liver Disease) is a collaborative research effort that aims to standardize, compare, and validate biomarkers for the non-invasive diagnosis and monitoring of NAFLD and NASH. NIMBLE partners with major pharmaceutical companies, academic centers, and key opinion leaders in industry, to evaluate candidate biomarkers for their suitability for wider implementation in clinical trials. AMRA Medical´s VAT biomarker was chosen as one of the primary biomarkers in the NIMBLE 1.2 study, showing excellent repeatability in patients with NAFLD.

The NIMBLE 1.2 study was designed to assess the potential of using MRI-based biomarkers longitudinally in NAFLD/NASH clinical trials. In this first paper, published by Fowler et al. in Radiology, the repeatability of liver fat, liver stiffness, and VAT was assessed in patients with NAFLD. AMRA’s VAT biomarker was assessed as the primary body composition biomarker, due to the connection between obesity, CVD, insulin resistance, and NAFLD. Data on other body composition biomarkers and metrics from AMRA have also been collected and will be reported in a future paper.

This study found that AMRA’s VAT biomarker was reproducible across vendors (common MRI scanner manufacturers), field strengths, and temporal assessments, which supports the use of this biomarker in large-scale clinical trials.

Learn more about AMRA Medical’s MRI-based services via our website or connect with our team of experts for a detailed discussion at info@amramedical.com.

About AMRA Medical

AMRA Medical is a health informatics company at the forefront of medical imaging and precision medicine. The company has developed a new global standard in body composition analysis, delivering multiple fat and muscle biomarkers with unrivaled accuracy and precision – all from a rapid whole-body MRI scan. AMRA offers clinical services and research services to support transformative care and vital decision-making, from clinical research to clinical care.

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