GE HealthCare has announced positive Phase I clinical trial results for its novel macrocyclic manganese-based magnetic resonance imaging (MRI) contrast agent. The first-in-human study, presented at the Contrast Media Research symposium in Oslo, Norway, indicated that the agent was well tolerated, with no serious adverse events, dose-limiting toxicities, or clinically relevant findings reported.
This development addresses growing concerns regarding gadolinium-based contrast agents, which are commonly used to enhance MRI images by improving the visualization of abnormal structures and lesions. Gadolinium retention in the body and its potential environmental impact have prompted the search for alternative contrast agents.
Potential Benefits of Manganese-Based Agent
The manganese-based contrast agent offers several potential advantages. Unlike gadolinium, manganese is naturally occurring in the body and is efficiently eliminated. The agent's relaxivity, which is comparable to that of gadolinium-based agents, suggests it could provide similar diagnostic image enhancement. According to Dr. Robert J. McDonald, Radiologist at Mayo Clinic and Contrast Media Safety Committee Board member for the American College of Radiology, 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.
Clinical Trial Details
The Phase I trial was conducted at Oslo University Hospital, Rikshospitalet, Norway, with partial funding from the Norwegian Research Council. The study evaluated the safety and tolerability of the manganese-based agent in healthy volunteers.
Future Directions
"These are encouraging Phase I results for this manganese-based contrast agent and we look forward to completing the next steps in the clinical development process," said Dr. Paul Evans, Head of Global R&D at GE HealthCare's Pharmaceutical Diagnostics business segment. The company aims to offer radiologists a broader portfolio of contrast agents to enable personalized care and address unmet patient needs.
