NCT03986138

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Detailed description

The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions. This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial. This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.

Conditions

• Lesion in Body Region

Interventions

Type	Name	Description
DRUG	gadopiclenol	Single intravenous bolus injection
DRUG	Gadobutrol 1 MMOLE/ML Intravenous Solution	Single intravenous bolus injection

Timeline

• Start date: 2019-08-27
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2019-06-14
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

33 sites across 11 countries: United States, Bulgaria, France, Germany, Hungary, Italy, Mexico, Poland, South Korea, Spain, Ukraine

Regulatory

• FDA-regulated drug study