Clinical trialNCT02034708CompletedPhase 4Interventional

Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors

SponsorGuerbetEnrollment279Primary Brain Tumor

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). 270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between. Each patient will, therefore, receive two MRI during his/her participation in the study. The two arms consist in : * Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI. * Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI. Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems. MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Kenneth Maravilla, MD
University of Washington Medical Center, Seattle, USA
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

32 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Colombia

Fundacion Abood Shaio
Bogotá, Colombia
Fundacion Cardioinfantil Instituto de Cardiologia
Bogotá, Colombia
Instituto Nacional de Cancerologia
Bogotá, Colombia
Centro Medico Imbanaco
Cali, Colombia
Fundacion Instituto de Alta Tecnologia Medica de Antioquia Iatm
Medellín, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia

Mexico

Hospital Cima
Chihuahua City, Chihuahua, Mexico
Morales Vargas Centro de Investigación S.C.
León, Guanajuato, Mexico
Centro Neurologico Abc
México, Mexico Distrito Federal, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Winsett Rethman S.A. de C.V.
Monterrey, Nuevo León, Mexico
Centro Regiomontano de Investigacion S.C.
Monterrey, Mexico
Clinical Research Institute S.C.
Tlanepantla, Mexico

South Korea

Chonbuk National Univ Hosp
Jeonju, Jeollabuk-do, South Korea
Chungbuk National University
Cheongju-si, North Chungcheong, South Korea
Seoul St.Mary Hospital
Seoul, Seocho-gu, South Korea
Asan Medical Center
Seoul, Songpa-Gu, South Korea
Ajou University Hospital
Suwon, South Korea

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Infinity Clinical Research, Llc
Hollywood, Florida, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Winthrop University Hospital Clinical Trials Center
Mineola, New York, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Musc (medical University of South Carolina)
Charleston, South Carolina, United States
Uvm Mri Center for Biomedical Imaging
Burlington, Vermont, United States
University of Washington Medical Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Dotarem®Gadovist®/Gadavist®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2014
Primary completion: 30 Sept 2015
Completion: 30 Sept 2015
Last update posted: 30 Dec 2016
Registered enrollment: 279
Registry id: NCT02034708

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.