A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or… (NCT07472491) | Clinical Trial Compass
RecruitingPhase 2/3
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
United States640 participantsStarted 2026-04-01
Plain-language summary
This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts:
* Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.
* Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.
The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).
Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.
* The participant is able and willing to comply with study procedures as described in the protocol.
* The participant has read, understood, signed and dated the ICF prior to any study procedures.
* Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging procedure such as computed tomography (CT), positron emission tomography (PET)/CT or MRI performed within 12 months prior to ICF signature.
* Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system \[only breast in the United States in compliance with local approved indications of gadobutrol\]) referred as part of standard care for contrast-enhancing MRI of the body. The suspicion may be based on a previous imaging procedure such as CT, PET/CT, ultrasound or MRI performed within 12 months prior to ICF signature.
* The participant is scheduled for a contrast-enhanced MRI examination of the CNS or a body region for clinical reasons and has agreed to have a second contrast-enhanced MRI examination for the purpose of this study.
* The participant is in a clinically stable condition (i.e., no acute dete…