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NCT07472491 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
A Phase 2 study, sponsored by GE Healthcare.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 640
- Enrollment target
NCT07472491: Recruiting Phase 2 study, sponsored by GE Healthcare.
NCT07472491 is a Phase 2 study that is actively recruiting participants, run by GE Healthcare. The registered enrollment target is 640 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (381% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07472491, a Phase 2 study, is actively recruiting participants, sponsored by GE Healthcare.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 640 participants
- Enrollment target
Study 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.
Primary Outcome
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Interventions
- DIAGNOSTIC_TEST MRI Scan
- DRUG Gadobutrol
- DRUG Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What NCT07472491 shows while recruiting
NCT07472491 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (381% higher).
The record links to 0 conditions, and to 3 interventions - of which MRI Scan is the first listed.
NCT07472491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07472491 about?
NCT07472491 is a clinical study titled "A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients". 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 p...
What is the current status of trial NCT07472491?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 640 participants. The study started on 2026-04-01. Estimated completion is 2027-11-30.
What interventions are being tested in trial NCT07472491?
The interventions under investigation include: MRI Scan (DIAGNOSTIC_TEST), Gadobutrol (DRUG), Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL (DRUG).
Who is sponsoring clinical trial NCT07472491?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07472491's enrollment target sits among peer trials
640 51st of 2000 higher than 1,950 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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