Resoundant Expands Services Offerings to Support Use of Quantitative Imaging Biomarkers in Clinical Trials
Kay Pepin, PhD is Manager, Research Translation for Resoundant.
Since Resoundant’s founding in 2010, our goal has always been to develop and implement MR Elastography for clinical use. As a highly accurate, non-invasive way to assess liver fibrosis, Mayo Clinic has embraced this patient-friendly approach to liver health, dramatically reducing the number of needle biopsies. Today, the hospital does over 1,350 MRE exams per year to stage liver fibrosis in patients.
However, in recent years, the rising prevalence and awareness of NAFLD/NASH has led to a surge in drug development in this area. This is incredibly helpful, as the complex pathophysiology and co-morbidities make lifestyle-led interventions seldom efficacious. There is wide consensus that therapeutic options will be needed if we are to stem the tide of this growing epidemic.
To this end, a number of trials into NAFLD and NASH candidates have deployed MRE in a number of contexts: as a primary endpoint, as an exploratory endpoint, or as part of a diagnostic screening protocol. MRE has the benefit of being quantitative, non-invasive, well-validated, widely available and highly accurate. In many clinical trials, Resoundant and Mayo Clinic have served in a number of formal and informal roles – from ad hoc trial design advice to a core lab doing central image analysis.
We’ve been privileged to see continued organic growth in this area – particularly for central imaging analysis of MRE and PDFF datasets. To meet this demand and implement the rigorous standards required of drug development work, Resoundant and Mayo Clinic are collaborating to formally offer these critical services through Resoundant Clinical Trials.
RCT services include advanced image analysis, central inversion processing, access to Mayo Clinic-trained analysts, study design consultation, site training, and more. We have implemented a best-in-class data management and security infrastructure that will work seamlessly with existing CRO and vendor platforms.
RCT combines content expertise and state of the art services to provide efficient and cost-effective solutions for quantitative imaging in clinical trials for liver disease – notably MRE and PDFF. Both techniques are best-in-class MRI protocols for assessing fibrosis and steatosis respectively, with excellent linearity, bias, and precision across different acquisition techniques (field strengths, scanner manufacturers, pulse sequences and reconstruction methods) [1, 2]. And RCT not only follows established standards for MRE acquisitions, but we helped create them! 
All in all, our goal is to use our expertise to serve imaging CROs by bringing down the cost of MRE while ensuring the highest quality analytics, data acquisition, and quality control.
1. Yokoo, T., et al., Linearity, Bias, and Precision of Hepatic Proton Density Fat Fraction Measurements by Using MR Imaging: A Meta-Analysis. Radiology, 2018. 286(2): p. 486-498.
2. Serai, S.D., et al., Repeatability of MR elastography of liver: a meta-analysis. Radiology, 2017. 285(1): p. 92-100.
3. QIBA MR Biomarker Committee. MR Elastography of the Liver, Quantitative Imaging Biomarkers Alliance. Profile Stage: Consensus. June 6, 2019. Available from: http://qibawiki.rsna.org/index.php/Profiles