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

Phase 3

Completed

Interventions: Drug: gadopiclenol
Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial

Brief Summary: This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Detailed Description: The purpose of this trial was 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 was conducted in 33 centers worldwide.

During the course of the trial, two MRIs were obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations were performed by on-site investigators and three independent off-site blinded readers.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI	gadopiclenol	cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI	Gadobutrol 1Mmol/mL Solution for Injection Vial	cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI	Gadobutrol 1Mmol/mL Solution for Injection Vial	cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI	gadopiclenol	cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI

Primary Outcome Measures

Name	Time	Method
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI	At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.	The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader.

Secondary Outcome Measures

Name	Time	Method
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI	At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations	The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.

Locations (33): ASCLEPES Research Centers
🇺🇸
Panorama City, California, United States
University of Connecticut Health Center
🇺🇸
Farmington, Connecticut, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Northwest Neurology, Ltd.
🇺🇸
Rolling Meadows, Illinois, United States
University of Missouri Hospital and Clinic
🇺🇸
Columbia, Missouri, United States
University Of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
South Carolina Clinical & Translational Research (SCTR) Institute
🇺🇸
Charleston, South Carolina, United States
University Of Washington - Medical Center
🇺🇸
Seattle, Washington, United States
ZNA Middelheim
🇧🇪
Antwerp, Belgium
UZ Brussel - Campus Jette
🇧🇪
Brussels, Belgium
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ASCLEPES Research Centers
🇺🇸Panorama City, California, United States