A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
← catalyst calendarNCT07472491 · readout in 468 d
Sponsored by GE Healthcare (industry) · GEHC — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Diagnostic
Enrollment
640estimated
Sites
7
Countries
Georgia, Moldova, South Korea +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-01 | actual | When the study began enrolling |
| Primary completion | 2027-11-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Known or Highly Suspected Central Nervous System (CNS) Lesion
- Known or Highly Suspected Body (Excluding CNS) Lesion
Interventions
- Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL
- Diagnostic test: MRI Scan
- Drug: Gadobutrol
Primary outcomes
what the primary-completion date above is the date OFPhase 2 Primary Endpoint - Overall diagnostic preference
measured 4-47 days
Phase 3 Primary Endpoint - Lesion visualization criteria
measured 4-74 days
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