Phase 3
N=304
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Lesion in Body Region
Bottom Line
View on ClinicalTrials.gov: NCT03986138 ↗Enrolled (actual)
304
Serious AEs
0.5%
Results posted
Oct 2025
Primary outcome: Primary: Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI — 3.79; 2.26; 3.48; 3.01 mean of a score (on a scale) per patient — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- gadopiclenol (Drug); Gadobutrol 1 MMOLE/ML Intravenous Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI |
3.79; 2.26; 3.48; 3.01; 3.49; 1.78 | < 0.0001 sig |
| SECONDARY Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI |
3.82; 3.81; 3.56; 3.53; 3.53; 3.57 | <0.0001 sig |
Summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Eligibility Criteria
Inclusion Criteria
- Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
Exclusion Criteria
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
Data sourced from ClinicalTrials.gov (NCT03986138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.