clinical trial · NCT03986138
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Guerbet·phase3·completed·n = 324
Lesion in Body RegiongadopiclenolGadobutrol 1 MMOLE/ML Intravenous Solution
brief summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
started
Aug 27, 2019
primary completion
Dec 9, 2020
completion
Dec 9, 2020
last updated
Oct 27, 2025
detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.
This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.
This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol