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GE HealthCare Announces First Patient Dosed in Phase 2/3 LUMINA Trial for Manganese-Based MRI Contrast Agent Under FDA Fast Track Designation, Further Advancing Its Innovation Pipeline of Novel Imaging Agents
Mangaciclanol, if approved, could transform contrast-enhanced MR imaging by offering an alternative to - or even replacing - gadolinium-based MRI agents A
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nMangaciclanol, if approved, could transform contrast-enhanced MR imaging by offering an alternative to - or even replacing - gadolinium-based MRI agents\n\n\n\nA manganese-based MRI contrast agent could address concerns with gadolinium-based contrast agents around retention in the body, security of supply, and the environment, with mangaciclanol’s clinical development under FDA Fast Track designation\n\n\n\nThe program demonstrates GE HealthCare’s commitment to advancing novel imaging agents to address unmet patient needs\n\n\n\n CHALFONT ST GILES, England--(BUSINESS WIRE)--\nGE HealthCare (Nasdaq: GEHC) today announced the first patient has been dosed in the international, multi-center Phase 2/3 LUMINA clinical trial of its manganese-based magnetic resonance imaging (MRI) contrast agent, mangaciclanol, at Mayo Clinic in Rochester, Minnesota. Mangaciclanol, if approved, could offer an alternative to – or even replace – gadolinium-based MRI contrast agents, the current standard of care. The investigational agent has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients aged 2 years and older with MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and the body. FDA Fast Track designation expedites the review of new therapeutics and medical imaging agents that have the potential to address significant unmet patient needs.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423262096/en/First-in-human contrast enhanced MRI images with GE HealthCare's mangaciclanol\nMRI contrast agents enhance the visualization of abnormal structures or lesions during imaging procedures and help clinicians better distinguish between healthy and diseased tissue. Mangaciclanol is intended for general-purpose MR imaging and demonstrates comparable relaxivity (the ability to enhance signal intensity) to market-leading gadolinium-based agent, gadobutrol, with early clinical images suggesting similar diagnostic capability. Unlike gadolinium, which is a rare-earth metal, manganese is present in our food, and is an endogenous element, naturally occurring and autoregulated in the body. The macrocyclic ‘cage-like’ structure of mangaciclanol lessens the possibility of retention.\n\n\nAp...