A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

AMRA Medical’s Whole-body MRI Analysis Used in FSHD Clinical Trial Research Network Study for Biomarker Development

AMRA Medical, a digital health company delivering a new standard in body composition analysis through rapid whole-body magnetic resonance imaging (MRI), today announced its involvement with the Facioscapulohumeral Muscular Dystrophy (FSHD) Clinical Trial Research Network (CTRN) to support the Motor Outcomes to Validate Evaluations Plus (MOVE+) Study—a natural history study for people living with FSHD.

MOVE+ is a sub-study of the ongoing natural history study called Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) and adds MRI—made possible in part through sponsorship by Avidity Biosciences, FSHD Society, Friends of FSH Research, and FSHD Canada. MOVE+ will enroll 200 participants across 12 sites in the US and two planned sites in Canada with the goal of better understanding how to utilize whole-body MRI to discover and validate specific biomarkers for FSHD that can inform future clinical trials. The results of this study will be particularly important for MOVE+ sponsoring companies like Avidity Biosciences—a biopharmaceutical company developing a new class of RNA therapeutics with an advancing and expanding pipeline that includes multiple skeletal muscle programs.

“The FSHD CTRN is very excited about our collaboration with AMRA. We think that the use of whole-body MRI will be important not only for trial planning, but to better understand and treat people with FSHD,” says Jeffrey Statland, MD, Professor of Neurology at the University of Kansas Medical Center, which also is the Clinical Coordinating Center for the FSHD CTRN.

To date, the MOVE study has used functional tests as primary outcomes, but recent studies have shown the promise of MRI for FSHD. To complement functional tests, MOVE+ will use AMRA’s whole-body, whole-muscle MRI protocol and analysis, which involves measuring 36 muscles throughout the participant’s shoulders, arms, torso and legs—distal to proximal and bilaterally. Specifically, the researchers will quantify muscle fat infiltration, lean muscle volume, and muscle fat fraction at twotime points throughout a three-year study period for each individual.

Evaluating entire muscles throughout the whole body provides a fuller picture of how the disease presents and progresses, which is critical to understand when searching for the most optimal outcome measurements to use in FSHD clinical trials. Not only is this applicable for FSHD, but also other neuromuscular disorders including DMD, LGMD, Myotonic Dystrophy, Mitochondrial Myopathy, SBMA, SIBM, and Pompe Disease.

Other past news.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy