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

Completed · Phase 4

Conditions studied: Primary Brain Tumor

In brief

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.

Key facts

Study ID: NCT02034708
Run by: Guerbet
People needed: 279
Starts: 2014-06-01
Expected to finish: 2015-09-01
Last updated by the study team: 2016-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Female or male adult patient (patient having reached legal majority age)
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)

You may not qualify if…

Patient with rapidly evolving brain tumor that could change in appearance between the time of the two study MRI examinations.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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