NCT07348640

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

A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

Detailed description

To prospectively compare the diagnostic performance of gadopiclenol with gadoterate meglumine given at a dose of 0.1 mmol/kg in the diagnosis and evaluation of vascular diseases of supra-aortic (carotid/vertebrobasilar), peripheral or abdominal/renal arteries using commercial MRI scanners and MRA sequences.

Conditions

• Steno-occlusive Disease

Interventions

Type	Name	Description
DRUG	gadopiclenol	Gadopiclenol enhanced-Magnetic Resonance Angiography
DRUG	Gadoterate meglumine (Dotarem)	Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-16
• Last updated: 2026-01-20

Locations

41 sites across 10 countries: United States, Canada, Czechia, France, Germany, Hungary, Italy, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study