Phase 3
N=256
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
CNS Lesion · Blood Brain Barrier Defect
Bottom Line
View on ClinicalTrials.gov: NCT03996447 ↗Enrolled (actual)
256
Serious AEs
0.2%
Results posted
Sep 2025
Primary outcome: Primary: Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI — 3.90; 2.08; 3.64; 1.74 mean of a score (on a scale) per patient — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- gadopiclenol (Drug); Gadobutrol 1Mmol/mL Solution for Injection Vial (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI |
3.90; 2.08; 3.64; 1.74; 3.97; 2.61 | <.0001 sig |
| SECONDARY Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI |
3.91; 3.93; 3.64; 3.60; 3.97; 3.95 | <0.0001 sig |
Summary
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Eligibility Criteria
Inclusion Criteria
- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
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 injection
- Patient presenting extra cranial lesions and/or extra-dural lesions.
Data sourced from ClinicalTrials.gov (NCT03996447). 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.