GE HealthCare doses first patient in LUMINA MRI trial

GE HealthCare has dosed the first patient in the international, multicenter phase 2/3 LUMINA trial of mangaciclanol, its investigational manganese-based MRI contrast agent. The patient was dosed at Mayo Clinic in Rochester, MN.

The agent has received FDA Fast Track designation for use in adults and pediatric patients ages 2 years and older. It is being studied for MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and body.

GE HealthCare said mangaciclanol, if approved, could offer an alternative to gadolinium-based MRI contrast agents, the current standard of care.

MRI contrast agents are used to improve visualization of abnormal structures or lesions during imaging. The company said the investigational agent has shown comparable relaxivity to gadobutrol, a market-leading gadolinium-based agent.

Unlike gadolinium, manganese is an endogenous element that occurs naturally in the body, according to GE HealthCare. The firm said the macrocyclic structure of mangaciclanol is designed to reduce the possibility of retention.

The company also cited supply considerations. GE HealthCare said gadolinium supply is largely dependent on mining and processing infrastructure in China, while manganese is available from countries including South Africa, Australia, and Gabon.

Phase 1 results showed the agent was well tolerated in a first-in-human trial, with no serious adverse events, no dose-limiting toxicities, and no clinically relevant findings reported, the company said.

Mangaciclanol remains in clinical development and is not approved for use.