GE HealthCare announces phase 1 results for a first-of-its-kind macrocyclic manganese-based MRI contrast agent

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GE HealthCare announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. The results, which will be used to support ongoing clinical development, concluded that in a first-in-human study, this manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported, according to an abstract presented at the 2024 bi-annual Contrast Media Research symposium in Oslo, Norway.

MRI contrast agents, which are typically gadolinium-based, are used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue. This macrocyclic, extra-cellular, general-purpose, manganese-based contrast agent has comparable relaxivity (the ability to enhance signal intensity) to gadolinium-based agents and is expected to be diagnostically similar to current gadolinium-based products. Manganese is naturally occurring in - and efficiently eliminated - from the body. Along with its suitable image-enhancing properties, this manganese-based agent could be a viable alternative to gadolinium, particularly in light of perceived concerns relating to gadolinium retention and the potential impact of post-patient excreted gadolinium in the environment.

Dr Robert J. McDonald, Radiologist at Mayo Clinic and Contrast Media Safety Committee Board member for the American College of Radiology, whose group has collaborated with GE HealthCare during the research phase, commented, “GE HealthCare’s manganese-based contrast agent could offer benefits such as reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents, while also providing comparable imaging capabilities and potentially lower environmental impact.”

The Phase I trial was undertaken at the clinical research unit at Oslo University Hospital, Rikshospitalet, Norway, and benefited from partial funding provided by the Norwegian Research Council. GE HealthCare has two contrast media facilities in Norway.