The clinical trial will be conducted at the Oslo University Hospital clinical research unit, under the guidance of lead investigator, Hasse K Zaré, to evaluate the safety profile of a new injectable manganese-based reagent
GE HealthCare to evaluate new contrast media. (Credit: Business Wire/ GE HealthCare)
GE HealthCare has completed patient recruitment in the Phase 1 clinical trial programme for its manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent.
The clinical trial will be conducted at the Oslo University Hospital clinical research unit, under the guidance of lead investigator Hasse K Zaré.
The study aims to evaluate the safety profile of the company’s new injectable manganese-based reagent, and how it is eliminated from the body in healthy volunteers.
MRI agents are used to enhance the visualisation of abnormal structures or lesions and to differentiate between healthy and pathological tissue and are mostly gadolinium-based.
The new manganese-based agent provides a potential alternative to gadolinium-based reagents and could widen its portfolio of MRI contrast agents, said GE HealthCare.
GE HealthCare pharmaceutical diagnostics unit global R&D head Paul Evans said: “For many years we’ve been committed to investing in, and bringing to market, products to help solve some of radiology’s biggest challenges and unmet needs.
“This manganese-based MRI agent is one of a number of novel agents we have at various stages of development in our innovation pipeline, all of which aim to give practitioners more choice in delivering precision care for their patients.”
The macrocyclic, extra-cellular manganese-based agent is designed to show similar relaxivity and performance as current gadolinium-based contrast agents (GBCAs).
Relaxivity is the ability of a contrast agent to enhance signal intensity during an MRI scan.
Unlike gadolinium, manganese is endogenous, a trace element that naturally occurs and can be effectively eliminated from the body.
In addition to magnetic properties, the manganese-based agent’s endogenous property makes it a feasible alternative to gadolinium, said GE HealthCare.
According to the company, previously developed manganese-based MRI agents work on a free manganese release mechanism.
GE HealthCare’s investigational agent is tightly bound to the chelate, in a macrocyclic cage-like structure, to be quickly eliminated from, rather than released into the body.