Clinical trial NCT03986138: Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Official title: Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lesion in Body Region
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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 administration.

Primary outcomes:
measure: Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI
timeFrame: 1 day procedure
measure: Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI
timeFrame: 1 day procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Farmington
country: United States
facility: UConn Health - University of Connecticut
state: Connecticut
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital Sofia
city: Angers
country: France
facility: CHU
city: Clichy la Garenne
country: France
facility: CHU Beaujon
city: Paris
country: France
facility: Hôpital Saint Louis
city: Aachen
country: Germany
facility: Klinik für Diagnostische und Interventionelle Radiologie
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: University Hospital Jena
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Bucheon Suncheonhyang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Estado de Mexico
country: Mexico
facility: Clinical Research Institute S.C.
city: Monterrey
country: Mexico
facility: Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Jagiellońskie Centrum Innowacji Sp. z o. o.
city: Kraków
country: Poland
facility: Szpital Świętego Rafała
city: Wałbrzych
country: Poland
facility: Centrum Medyczne Affidea Wałbrzych
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Kropyvnytskyi
country: Ukraine
facility: St. Luke's Hospital
city: Kyiv
country: Ukraine
facility: Borys Clinic
Study officials:
References: