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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 is a Phase 2 study that is actively recruiting participants, run by GE Healthcare. The registered enrollment target is 640 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07472491
The ClinicalTrials.gov registry entry for NCT07472491 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MRI Scan is the first listed.
NCT07472491 reports 0 study locations.
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.
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