News | Contrast Media | March 09, 2023

Reveal Pharmaceuticals doses first subjects in Phase 1 Clinical Trial of RVP‑001

Reveal Pharmaceuticals doses first subjects in Phase 1 Clinical Trial of RVP‑001

March 9, 2023 — Contrast agents used in MRI scans to improve the clarity of imaging for diagnostic accuracy, accumulate in the brain and body of every patient, and carry an FDA “black box” warning about gadolinium, a heavy metal they use to generate contrast. Now, a revolutionary gadolinium-free contrast agent, RVP‑001, designed to provide safer contrast-enhanced MRIs for patients and to directly replace current MRI contrast agents, is being tested for the first time in a clinical trial. Reveal Pharmaceuticals has dosed the first subjects in the Phase 1 clinical trial of RVP‑001. 

“The start of clinical trials is a tremendous milestone in advancing patient care,” said Vera Hoffman, CEO of Reveal. “Despite years of effort, this is the first time a general-purpose gadolinium-free contrast agent has been innovated and clinically tested.” 

The Phase 1 study is designed to determine the safety, tolerability, and pharmacokinetics of RVP‑001. Each year over 40 million contrast-enhanced (CE) MRI scans are used to diagnose and manage many serious health conditions. Gadolinium used in CE‑MRI scans not only impacts patients with buildup of the heavy metal in the brain and body, but also impacts the environment by driving rising levels of gadolinium in the earth’s surface waters. Instead of gadolinium, RVP‑001 uses manganese, which is essential for life and naturally found in the body.  

RVP‑001 was invented by Peter Caravan and Eric Gale at Harvard Medical School/ Massachusetts General Hospital. The National Cancer Institute, part of the National Institutes of Health, is funding the US-based clinical trial. 

“RVP‑001 promises to directly replace gadolinium-based contrast agents and use established radiology protocols developed over decades of CE-MRI,” said Srinivasan Mukundan, Reveal’s medical director and former chief of MRI and Neuroradiology at Brigham Health. “Physicians and patients increasingly avoid CE-MRI due to concerns about gadolinium.  Gadolinium-free RVP‑001 allays these concerns and provides promise for patients to receive the imaging studies they need.” 

Reveal Pharmaceuticals’ mission is to improve patient care with transformative advances in medical insight: its gadolinium-free contrast agent has won support from three institutes of the NIH and from Massachusetts Life Sciences Center, MassChallenge, and MassVentures. Reveal’s pipeline focuses on molecular imaging of fibrogenesis. 

This trial (NCT05413668) is supported by SBIR grant R44CA268392 from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and may not represent the official views of the NIH.  

For more information: www.revealpharma.com 

 

Related Content of MRI Gadolinium Safety Concerns 

The Debate Over Gadolinium MRI Contrast Toxicity 

VIDEO: How Serious is MRI Gadolinium Retention in the Brain and Body? An interview with Max Wintermark, M.D. 

VIDEO “Big Concerns Remain for MRI Gadolinium Contrast Safety at RSNA 2017,” An interview with Emanuel Kanal, M.D. 

Radiology Has Failed to Properly Assess or Track MRI Gadolinium Contrast Safety 

Recent Developments in Contrast Media 

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents 

European Medicines Agency Issues Update on Gadolinium Contrast Agents 

ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents 

FDA: No Harm in MRI Gadolinium Retention in the Brain 

VIDEO: MRI Gadolinium Contrast Retention in the Brain 

Gadolinium May Remain in Brain After Contrast MRI


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