Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
NCT ID: NCT02034708
Last Updated: 2016-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
279 participants
INTERVENTIONAL
2014-06-30
2015-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Dotarem®/Gadovist®
Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
Dotarem®
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
Gadovist®/Dotarem®
Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
Dotarem®
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
Interventions
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Dotarem®
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
Eligibility Criteria
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Inclusion Criteria
* Patient with known or highly suspected primary intracranial tumors (intra-axial or extra-axial) detected by previous CT or MRI examination who are scheduled to undergo a routine contrast-enhanced MRI
* Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
* Patient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conducted
* Patient with national health insurance (according to local regulatory requirements)
Exclusion Criteria
* Patient undergoing current or recent treatment within past 6 weeks or scheduled for any treatment that could results in changes of lesion appearance between the two study examinations. This would include, but not restricted to, the following: current or recent radiation therapy, surgery, starting or recent chemotherapy.
* Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to the imaging site standard practice)
* Patient with known severely impaired renal function (defined as eGFR MDRD\< 30 ml/min/1.73m2)
* Patient with known Class III/IV congestive heart failure according to the New York Heart Association classification
* Patient with known severe adverse drug reaction or contraindication to Gadolinium-Based Contrast Agent
* Patient having received any contrast agent within 48 hours prior to first study contrast agent injection scheduled for the study and patient expected to receive any other contrast agent within 24 hours of the last study contrast agent injection
* Patient presenting with any condition which, based on the investigator's clinical judgment, would prevent the patient from completing all trial assessments and visits
* Patient under guardianship and/or unable or unwilling to cooperate with the requirements of this trial
* Pregnant or breast feeding female patient
* Patient already included in this trial
* Patient included in another clinical trial involving an IMP within 30 days before the first investigational contrast agent injection.
18 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Maravilla, MD
Role: STUDY_CHAIR
University of Washington Medical Center, Seattle, USA
Locations
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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
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
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
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
Countries
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Other Identifiers
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DGD-44-058
Identifier Type: -
Identifier Source: org_study_id