Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
- Conditions
- Lesion in Body Region
- Interventions
- Registration Number
- NCT03986138
- Lead Sponsor
- Guerbet
- Brief Summary
The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
- Detailed Description
The purpose of this trial is 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 will be conducted in approximately 50 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations will be assessed by independent off-site blinded readers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
- 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 administration.
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 receives gadopiclenol for the first MRI and then gadobutrol for the second MRI gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI Gadobutrol 1 MMOLE/ML Intravenous Solution Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI Gadobutrol 1 MMOLE/ML Intravenous Solution Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI gadopiclenol Cross-over design: each patient receives gadobutrol for the first MRI and then 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 by independent blinded readers on the images acquired during the MRI performed with gadopiclenol for up to 3 most representative lesions
Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced 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 by independent blinded readers on the images acquired during the MRI performed with gadopiclenol and MRI performed with gadobutrol for up to 3 most representative lesions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Jagiellońskie Centrum Innowacji Sp. z o. o.
🇵🇱Kraków, Poland
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
UConn Health - University of Connecticut
🇺🇸Farmington, Connecticut, United States
Acibadem City Clinic Tokuda Hospital Sofia
🇧🇬Sofia, Bulgaria
Hôpital Saint Louis
🇫🇷Paris, France
CHU
🇫🇷Angers, France
CHU Beaujon
🇫🇷Clichy la Garenne, France
Klinik für Diagnostische und Interventionelle Radiologie
🇩🇪Aachen, Germany
Universitätsklinikum Halle
🇩🇪Halle, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Somogy Megyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvár, Hungary
University Hospital Jena
🇩🇪Jena, Germany
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
🇭🇺Szolnok, Hungary
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
🇮🇹Napoli, Italy
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Bucheon Suncheonhyang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Clinical Research Institute S.C.
🇲🇽Estado de Mexico, Mexico
Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Poland
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center
🇲🇽Monterrey, Mexico
Szpital Świętego Rafała
🇵🇱Kraków, Poland
Centrum Medyczne Affidea Wałbrzych
🇵🇱Wałbrzych, Poland
Borys Clinic
🇺🇦Kyiv, Ukraine
St. Luke's Hospital
🇺🇦Kropyvnytskyi, Ukraine
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States