Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- Conditions
- CNS LesionBlood Brain Barrier Defect
- Interventions
- Registration Number
- NCT03996447
- Lead Sponsor
- Guerbet
- Brief Summary
the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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.
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 mยฒ assessed within 1 day prior to each contrast agent injection
- Patient presenting extra cranial lesions and/or extra-dural lesions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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 criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI 1 day procedure The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions.
Lesion visualization criteria for gadopiclenol compared to gadobutrol 1 day procedure the lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol and those performed with gadobutrol.
For each reader, only matching lesion between paired images of gadobutrol and gadopiclenol will be considered
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
UZ Brussel - Campus Jette
๐ง๐ชBrussel, Belgium
South Carolina Clinical & Translational Research (SCTR) Institute
๐บ๐ธCharleston, South Carolina, United States
Debreceni Egyetem Klinikai Kozpont
๐ญ๐บDebrecen, Hungary
Semmelweis Egyetem - Neurology
๐ญ๐บBudapest, Hungary
Orszagos Klinikai Idegtudomanyi Intezet
๐ญ๐บBudapest, Hungary
Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.
๐ฎ๐นPozzilli, Italy
CHU La Miletrie
๐ซ๐ทPoitiers, France
Hospital del Mar
๐ช๐ธBarcelona, Spain
ZNA Middelheim
๐ง๐ชAntwerp, Belgium
Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara
๐ฎ๐นTrieste, Italy
CHRU Strasbourg Hรดpital de Hautepierre
๐ซ๐ทStrasbourg, France
ASCLEPES Research Centers
๐บ๐ธPanorama City, California, United States
Uniklinik Mannheim
๐ฉ๐ชMannheim, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
๐ญ๐บPรฉcs, Hungary
University Of Washington - Medical Center
๐บ๐ธSeattle, Washington, United States
CHRU - Hรดpital Roger Salengro - Neurologie
๐ซ๐ทLille, France
University Of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Uniwersyteckie Centrum Kliniczne w Gdaลsku, Zakลad Radiologii
๐ต๐ฑGdaลsk, Poland
Hospital Clรญnico San Carlos
๐ช๐ธMadrid, Spain
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Clinical Research Institute S.C
๐ฒ๐ฝTlalnepantla de Baz, Mexico
University of Connecticut Health Center
๐บ๐ธFarmington, Connecticut, United States
Szegedi Tudomanyegyetem AOK
๐ญ๐บSzeged, Hungary
Centre Hospitalier Sainte-Anne
๐ซ๐ทParis, France
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore
๐ฎ๐นL'Aquila, Italy
Taipei Veterans General Hospital
๐จ๐ณTaipei, Taiwan
Konkuk University Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
M.D. Anderson Cancer Center Madrid
๐ช๐ธMadrid, Spain
Fondazione I.R.C.C.S. C.Mondino
๐ฎ๐นPavia, Italy
Northwest Neurology, Ltd.
๐บ๐ธRolling Meadows, Illinois, United States
Northwestern Memorial Hospital
๐บ๐ธChicago, Illinois, United States
University of Missouri Hospital and Clinic
๐บ๐ธColumbia, Missouri, United States
Axis Heilsa S. de R.L. de C.V. (Althian)
๐ฒ๐ฝMonterrey, Mexico