Evaluating Mangaciclanol Compared to Gadobutrol for MRI Detection of CNS and Body Lesions in Adults

What this Trial Is About

Researchers are conducting a combined Phase 23 study to evaluate the diagnostic effectiveness and safety of mangaciclanol compared to gadobutrol for contrast-enhanced MRI in adult patients with known or suspected lesions of the central nervous system CNS or other body regions. Phase 2 focuses on identifying the best dose of mangaciclanol, while Phase 3 aims to further assess its performance and safety in detecting and characterizing lesions using enhanced MRI imaging techniques. In Phase 2, participants receive a single intravenous dose of mangaciclanol or gadobutrol, followed by MRI scans that last up to 60 minutes post-administration. Dose finding is conducted with approximately 60 participants and may include a second cohort based on initial results. Phase 3 involves a randomized crossover design where participants receive both mangaciclanol and gadobutrol in sequence, allowing direct comparison. Both drugs are administered intravenously with a saline flush, and MRI scans are performed to evaluate lesion visualization. Participants undergo two contrast-enhanced MRI scans as part of the study, with assessments including lesion visualization criteria, number of lesions, image quality, and technical adequacy. Safety is monitored through adverse event reporting, laboratory tests, vital signs, physical exams, and electrocardiograms. Primary outcomes include diagnostic preferences and lesion visualization evaluated within 4 to 74 days of imaging. The study is expected to last until November 2027, with careful monitoring of participant condition and adherence throughout the trial.

A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients