Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Guerbet
- Study ID
- NCT07348640
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Steno-occlusive Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- gadopiclenol — DRUGGadopiclenol enhanced-Magnetic Resonance Angiography
- Gadoterate meglumine (Dotarem) — DRUGGadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography
Study Details
Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
Key Dates
- Start date
- Feb 2, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 315 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: ABGadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg
- Active Comparator: BAGadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol
Primary Outcome Measure
Non-inferiority [ Time Frame: 30 days ]
Central Contacts
- Sophie Rollin, PhD+33688196716
- Frantz Hébert, MSc
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Los Angeles (UCLA) | Los Angeles | California | 90095-7206 | |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | |
| Northshore - Evanston Hospital | Evanston | Illinois | 60201 | |
| Mayo Clinic | Rochester | Minnesota | 55901 | |
| Houston Methodist Hospital | Houston | Texas | 77030 | |
| University of Washington | Seattle | Washington | 98185 |