FDA greenlights clinical trials testing novel MRI contrast agent for prostate cancer
Case Western Reserve University has gained federal approval for clinical trials to test its MRI contrast agent used to detect prostate cancer, the noted research institution announced Thursday.
The gadolinium-based material, known as MT218, can enhance imaging signals of aggressive tumors and improve patients’ cancer diagnoses. The first phase will test its safety profile and is expected to enroll 30 healthy Black and white males between 18 and 55.
Recruitment will kick off early next month with the trial starting later in May.
“We are very excited about this phase one clinical trial because it means that our research product is now under clinical development to help people,” said Zheng-Rong Lu, PhD, a professor of Biomedical Engineering at Case Western who has been central in developing the contrast material. “Our agent has the promise to detect the aggressive solid tumors to provide imaging guidance for precision healthcare of cancer patients.”
Molecular Theranostics, a Cleveland-based startup, owns the license for MT218, along with its partners Jiangsu Motek Pharmaceuticals of China and U.S. Motek. The latter is contracting with Ohio Clinical Trials Inc. to perform the initial clinical tests.
The organizations are also pursuing a second trial to assess the imaging agent’s effectiveness in detecting aggressive tumors and differentiating between tumor types.
Sampling errors with “gold standard” biopsy lead to false-negatives in up to 30% of patients, Lu noted. And blood tests followed by additional biopsy can also lead to overtreatment and serious side effects.
With this new imaging agent, Lu hopes to reverse these harmful trends.
“That’s why this is so important,” Lu, who is also co-founder of Molecular Theranostics, explained. “Research shows that only 20% of patients diagnosed will develop aggressive tumors—so we could spare the other 80% from aggressive overtreatment.”
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.