Second phase of trial testing GE HealthCare's GBCA alternative gets underway
The first patient has officially been dosed with GE HealthCare’s investigational manganese-based magnetic resonance imaging (MRI) contrast agent, according to an announcement from the company.
Experts are hopeful that mangaciclanol could offer a viable alternative to gadolinium-based contrast agents that are typically used to enhance MRIs. The macrocyclic "cage-like" structure of mangaciclanol reduces the likelihood of retention—a significant concern with GBCA use. It was recently granted the U.S. Food and Drug Administration’s Fast Track designation, as early clinical testing has been promising.
The international, multicenter, Phase 2/3 LUMINA clinical trial is testing the safety and efficacy of the agent. This week, the first patient received an injection of mangaciclanol during an MRI scan at the Mayo Clinic in Rochester, Minnesota.
“Existing gadolinium-based contrast agents carry safety language associated with gadolinium retention. In comparison, mangaciclanol could offer an alternative for broad patient groups, including vulnerable patients and those requiring multiple scans, while still offering similar diagnostic performance,” Jit Saini, MD, chief medical officer of pharmaceutical diagnostics at GE HealthCare, said in a news release. “The FDA Fast Track designation recognizes the potential significance of mangaciclanol and aligns with our focus on advancing its development for patients.”
The first phase of the LUMINA trial yielded positive results. The agent was well tolerated, had no dose limiting toxicities and offered diagnostic quality image enhancement. What’s more, manganese also is more readily available than gadolinium, which could help address supply chain challenges and increase accessibility—an important consideration amid growing demand for MR imaging.
“As demand for diagnostic imaging continues to rise, we continue to advance our imaging agent pipeline to better meet the needs of patients,” added Peter Arduini, president and CEO, GE HealthCare. “This clinical milestone builds on GE HealthCare’s leadership in contrast media, as mangaciclanol has the potential to transform the MR imaging market and strengthen the resiliency of its supply chain.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.