At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 324 enrolled
Drug / intervention
gadopiclenol +1 moredrug
Likely dose
Single intravenous bolus injection (gadopiclenol) or gadobutrol 1 MMOLE/MLAI-extracted
Key inclusion· 1
- ✓Known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region documented on imaging within 12 months prior to enrollment
Key exclusion· 1
- ✕Acute or chronic renal insufficiency with eGFR <30 mL/min/1.73 m²
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
In Brief
A Phase 3 clinical trial evaluating gadopiclenol and Gadobutrol 1 MMOLE/ML Intravenous Solution for Lesion in Body Region. Completed, enrolled 324 participants across 33 sites in 11 countries.
Detailed Summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLesion in Body Region
CountriesBulgaria, France, Germany, Hungary, Italy, Mexico, Poland, South Korea, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartAug 2019
Primary CompletionDec 2020
TodayJul 2026
First PostedJun 14, 2019
Enrollment StartAug 27, 2019
Primary CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.0 years ago
Interventions
gadopiclenoldrug
Single intravenous bolus injection
Gadobutrol 1 MMOLE/ML Intravenous Solutiondrug
Single intravenous bolus injection