
GE HealthCare has today announced, at the European Congress of Radiology (ECR) in Vienna, Austria, the completion of Phase I subject recruitment in its early clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. Typically, MRI agents – used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue – are gadolinium-based. This manganese-based agent could broaden GE HealthCare’s portfolio of MRI contrast agents available to radiologists, providing a potential alternative in light of perceived concerns relating to gadolinium retention.
The macrocyclic, extra-cellular – or general-purpose – manganese-based contrast agent has comparable relaxivity - the ability of a contrast agent to enhance signal intensity during an MRI scan - and is expected to be diagnostically similar to current gadolinium-based contrast agents (GBCAs). Unlike gadolinium, manganese is endogenous, meaning that it is a trace element that is naturally occurring in and efficiently eliminated from the body. Along with its magnetic properties, this makes a manganese-based agent a viable alternative to gadolinium. In addition, a non-gadolinium agent could help limit the potential impact of post-patient excreted gadolinium in the environment.
The clinical trial, based at the clinical research unit at the Oslo University Hospital, Rikshospitalet, Norway, and overseen by Lead Investigator, Hasse K. ZarĂ©, aims to investigate the safety profile and how this injectable manganese contrast agent is eliminated from the body in healthy volunteers. Previous manganese-based MRI agents have been reliant on a ‘free manganese’ release mechanism for their imaging efficacy. This novel investigational agent is tightly bound to the chelate, in a macrocyclic cage-like structure, so it is rapidly eliminated from - rather than actively released into - the body.