Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) — PICTURE  

Blood Brain Barrier Defect Clinical Trial

Official title: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Status Completed

Clinical Trial Summary

the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Clinical Trial Description

The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. . This is a multi-center, international, prospective, double-blind, randomized, controlled,cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS. This trial will be conducted in approximately 40 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations will be performed by on-site investigators and three independent off-site blinded readers. ;

Related Conditions & MeSH terms

• Blood Brain Barrier Defect
• CNS Lesion

• NCT number: NCT03996447
• Study type: Interventional
• Source: Guerbet
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2019
• Completion date: September 11, 2020