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GE HealthCare Announces Completion of Phase I Subject Recruitment in Early Clinical Development Program for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
GE HealthCare has completed Phase I subject recruitment for a novel manganese-based macrocyclic MRI contrast agent. Announced at the European Congress of Radiology in Vienna, this investigational agent offers a potential alternative to traditional gadolinium-based agents, addressing concerns about gadolinium retention in the body. The clinical trial, led by Hasse K. Zaré at Oslo University Hospital, aims to assess its safety and elimination profile. Manganese, being naturally occurring in the body, ensures efficient excretion, positioning this agent as a promising addition to GE HealthCare's portfolio in precision imaging.
Positive
Completion of Phase I subject recruitment for a novel manganese-based MRI agent.
Potential alternative to gadolinium-based agents, addressing retention concerns.
Manganese's natural occurrence and efficient elimination from the body.
Negative
None.
Novel manganese-based macrocyclic Magnetic Resonance Imaging (MRI) agent could offer an alternative to gadolinium-based agents
Manganese is a trace element naturally occurring in, and efficiently eliminated from, the human body
The clinical trial program demonstrates GE HealthCare’s commitment to innovation in contrast media and to building a portfolio of MRI imaging agents to address radiologists’ needs for their patients
CHALFONT ST GILES, England--(BUSINESS WIRE)--
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.
GE HealthCare is innovating in contrast media (Photo: Business Wire)
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. Zaré, 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.
Dr Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics unit, 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.”
GE HealthCare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. For more than 40 years, GE imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits.
What is the purpose of the manganese-based MRI agent developed by GE HealthCare?
The manganese-based MRI agent aims to provide a safer alternative to gadolinium-based agents, addressing concerns regarding gadolinium retention in patients.
When was the Phase I recruitment for the manganese-based MRI agent completed?
The Phase I subject recruitment was completed recently, with the announcement made at the European Congress of Radiology held in Vienna.
What are the expected benefits of the manganese-based MRI agent?
The manganese-based agent is expected to have comparable relaxivity to gadolinium-based agents while being naturally occurring and efficiently eliminated from the body.
Where is the clinical trial for the manganese-based MRI agent taking place?
The clinical trial is based at Oslo University Hospital, Rikshospitalet in Norway.
What is GE HealthCare's commitment regarding MRI agents?
GE HealthCare is committed to innovation in contrast media, focusing on developing a diverse portfolio of MRI imaging agents to meet the needs of radiologists.
