GE HealthCare has initiated patient dosing in a late-stage clinical trial evaluating a manganese-based MR contrast agent as a potential alternative to gadolinium-based products.

The Chicago-based company said the first participant in the Phase 2/3 LUMINA study received mangaciclanol at Mayo Clinic in Rochester, Minnesota. The multicenter trial is designed to assess the investigational agent’s ability to detect lesions with abnormal vascularity across the central nervous system and other body regions. The U.S. Food and Drug Administration has granted the agent Fast Track designation for use in adults and children age 2 and older, a status intended to speed development and review of products addressing unmet clinical needs.

MR contrast agents are used in roughly one-third of imaging procedures to improve visualization of tissue abnormalities. Gadolinium-based agents remain the standard, with an estimated 65 million contrast-enhanced MR exams performed globally each year. However, safety labeling related to gadolinium retention in the body has prompted ongoing evaluation of alternatives.
Mangaciclanol uses manganese, an element naturally present in the body, and incorporates a macrocyclic structure designed to limit retention. According to GE HealthCare, early clinical data suggest imaging performance comparable to gadobutrol, a commonly used gadolinium-based agent. Phase 1 results indicated the agent was well tolerated, with no serious adverse events or dose-limiting toxicities reported.

“Existing gadolinium-based contrast agents carry safety language associated with gadolinium retention,” said Dr. Jit Saini, chief medical officer of Pharmaceutical Diagnostics at GE HealthCare. “In comparison, mangaciclanol could offer an alternative for broad patient groups, including vulnerable patients and those requiring multiple scans, while still offering similar diagnostic performance.”

Beyond clinical considerations, the company pointed to supply and environmental factors. Gadolinium is a rare-earth element with supply chains concentrated in China, while manganese is more widely available globally. GE HealthCare also noted that manganese-based agents may reduce concerns about contrast media entering water systems after excretion.

Mangaciclanol remains investigational and has not received regulatory approval.

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