CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
gadopiclenol +1 moredrug
Likely dose
gadopiclenol 2mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996447
NCT03996447Phase 3Completed

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Guerbet·interventional·Posted Jun 24, 2019·Updated Sep 22, 2025

In Brief

A Phase 3 clinical trial evaluating gadopiclenol and Gadobutrol 1Mmol/mL Solution for Injection Vial for CNS Lesion and Blood Brain Barrier Defect. Completed, enrolled 260 participants across 33 sites in 11 countries.

Detailed Summary

This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Hungary, Italy, Mexico, Poland, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 24, 2019
Enrollment StartJun 3, 2019
Primary CompletionSep 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.0 years ago

Interventions

gadopiclenoldrug

single intravenous (IV) bolus injection at a rate of 2ml/second

Gadobutrol 1Mmol/mL Solution for Injection Vialdrug

single intravenous (IV) bolus injection at a rate of 2ml/second