MRI contrast agents are substances used to improve the visualisation of internal structures during MRI imaging. Credit: Aleksandar Malivuk / Shutterstock.

GE HealthCare has announced positive results from a Phase I study of its manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. 

Data from the first-in-human trial – presented at the Contrast Media Research symposium 2024 in Oslo, Norway – showed that themacrocyclic manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported. 

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MRI contrast agents are substances used to improve the visualisation of internal structures during MRI imaging. Most of these agents are gadolinium based (GBCA), due to its paramagnetic properties. However, gadolinium can be toxic if it accumulates in the body, especially in patients with kidney issues. As a safer alternative, researchers are exploring manganese, which is also paramagnetic, but naturally occurs, is processed, and cleared by the body. 

Conducted at the Oslo University Hospital, Rikshospitalet, clinical research unit in Norway, the clinical study assessed the safety profile of the injectable manganese contrast agent, as well as how it was discarded from the body, in healthy volunteers. 

Robert 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, said: “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.” 

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GE HealthCare said that if approved, this agent could address the potential impact of post-patient excreted gadolinium in the environment. Data has shown that GBCAs are present in sewage water, surface water, and drinking water in many regions of the world, and constitute an environmental risk. 

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GE HealthCare has a range of MRI contrast agents under its belt, including macrocyclic Clariscan (gadoteric acid), and Rapiscan (regadenoson), used in stress cardiac MRI to aid diagnosis of coronary artery disease. In April 2023, the company expanded its MRI contrast agent portfolio with the launch of Pixxoscan (gadobutrol). Pixxoscan is intended for contrast enhancement in cranial and spinal MRI as well as magnetic resonance angiography. 

The global diagnostic imaging market was worth $31.9bn in 2023 and is expected to grow to $45.8bn in 2030, mainly driven by an increase in the prevalence of chronic diseases and increased demand for imaging procedures from an aging population, as per GlobalData analysis.