Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Conditions
Primary Brain Tumor
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Primary brain tumor
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Intervention
Name: Dotarem® Type: Drug
Name: Gadovist®/Gadavist® Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
University of Arizona Medical Center
Tucson, Arizona, United States
Status: Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Not yet recruiting
Yale University School Of Medicine
New Haven, Connecticut, United States
Status: Not yet recruiting
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Status: Recruiting
University of Michigan Health System
Ann Arbor, Michigan, United States
Status: Not yet recruiting
Quest Research Institute
Farmington Hills, Michigan, United States
Status: Recruiting
Spectrum Health
Grand Rapids, Michigan, United States
Status: Not yet recruiting
Washington University
St. Louis, Missouri, United States
Status: Recruiting
Winthrop University Hospital Clinical Trials Center
Mineola, New York, United States
Status: Not yet recruiting
Temple University Hospital
Philadelphia, Pennsylvania, United States
Status: Recruiting
MUSC (Medical University of South Carolina)
Charleston, South Carolina, United States
Status: Recruiting
UVM MRI Center for Biomedical Imaging
Burlington, Vermont, United States
Status: Recruiting
University of Washington Medical Center
Seattle, Washington, United States
Status: Recruiting
Fundacion Abood Shaio
Bogota, Colombia
Status: Recruiting
Fundacion Cardioinfantil Instituto de Cardiologia
Bogota, Colombia
Status: Not yet recruiting
Instituto Nacional de Cancerologia
Bogota, Colombia
Status: Not yet recruiting
Centro Medico Imbanaco
Cali, Colombia
Status: Recruiting
Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM
Medellin, Colombia
Status: Recruiting
Hospital Pablo Tobon Uribe
Medellin, Colombia
Status: Recruiting
Chungbuk National University
Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Status: Recruiting
Chonbuk national Univ Hosp
Jeonju-si, Jeollabuk-do, Korea, Republic of
Status: Recruiting
Seoul St.Mary Hospital
Seoul, Seocho-gu, Korea, Republic of
Status: Recruiting
Asan medical center
Seoul, Songpa-Gu, Korea, Republic of
Status: Recruiting
Morales Vargas Centro de Investigación S.C.
Leon, Guanajuato, Mexico
Status: Not yet recruiting
Centro Neurologico ABC
Mexico, Mexico Distrito Federal, Mexico
Status: Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo Leon, Mexico
Status: Recruiting
Winsett Rethman S.A. de C.V.
Monterrey, Nuevo León, Mexico
Status: Recruiting
Hospital CIMA
Chihuahua, Mexico
Status: Recruiting
Centro Regiomontano de Investigacion S.C.
Monterrey, Mexico
Status: Recruiting
Clinical Research Institute S.C.
Tlanepantla, Mexico
Status: Recruiting
Start Date
June 2014
Completion Date
October 2015
Sponsors
Guerbet
Source
Guerbet
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page