Phase 3
Completed N=256
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
CNS Lesion · Blood Brain Barrier Defect
Source: ClinicalTrials.gov NCT03996447 ↗
Enrolled (actual)
256
Serious AEs
0.2%
Results posted
Sep 2025
Primary outcomePrimary: 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
◆ Published Evidence
Established
72citations · ~24 / year
Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial.
Summary
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Linked Publications
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Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.