Trial intelligence / Profile preview

Gadopiclenol for CNS MRI

NCT03996447Phase 3

Key facts

Status: Completed
Start: Jun 2019
Primary completion: Sep 2020
Countries: 11
Sponsor: Guerbet
Modality: Small Molecules

Drugs: gadopiclenol

Overview

Phase 3, randomised, double-blind trial of gadopiclenol (2 arms), sponsored by Guerbet. Primary endpoint: Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI. Started Jun 2019; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Arm 1
Gadopiclenol first, then gadobutrol
Arm 2
Gadobutrol first, then gadopiclenol

Who it enrols

Patients with known or highly suspected CNS lesions with focal areas of disrupted blood-brain barrier (e.g., primary and secondary tumors) based on prior imaging within 12 months, with eGFR ≥30 mL/min/1.73m², excluding extra-cranial and extra-dural lesions

Endpoints

Primary

Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRIsecond MRI for Arm 2 (2-14 days after first)

Secondary

Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRIboth MRI examinations with 2-14 days interval

Results

Primary endpoints met

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