- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034708
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors (REMIND)
Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bogota, Colombia
- Fundacion ABOOD Shaio
-
Bogota, Colombia
- Fundación CardioInfantil Instituto de Cardiología
-
Bogota, Colombia
- Instituto Nacional de Cancerologia
-
Cali, Colombia
- Centro Medico Imbanaco
-
Medellin, Colombia
- Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM
-
Medellin, Colombia
- Hospital Pablo Tobon Uribe
-
-
-
-
-
Suwon, Korea, Republic of
- Ajou University Hospital
-
-
Chungcheongbuk-do
-
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
- Chungbuk National University
-
-
Jeollabuk-do
-
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
- Chonbuk national Univ Hosp
-
-
Seocho-gu
-
Seoul, Seocho-gu, Korea, Republic of, 137-701
- Seoul St.Mary Hospital
-
-
Songpa-Gu
-
Seoul, Songpa-Gu, Korea, Republic of, 138-736
- Asan Medical Center
-
-
-
-
-
Chihuahua, Mexico, 31238
- Hospital CIMA
-
Monterrey, Mexico
- Centro Regiomontano de Investigacion S.C.
-
Tlanepantla, Mexico
- Clinical Research Institute S.C.
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37000
- Morales Vargas Centro de Investigación S.C.
-
-
Mexico Distrito Federal
-
Mexico, Mexico Distrito Federal, Mexico, 5300
- Centro Neurologico ABC
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 64020
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico
- Winsett Rethman S.A. de C.V.
-
-
-
-
Alabama
-
Birmingham, Alabama, United States
- University of Alabama at Birmingham
-
-
Arizona
-
Tucson, Arizona, United States, AZ 85724
- University of Arizona Medical Center
-
-
California
-
Los Angeles, California, United States
- Cedars-Sinai Medical Center
-
-
Connecticut
-
New Haven, Connecticut, United States
- Yale University School Of Medicine
-
-
Florida
-
Hollywood, Florida, United States, FL 33021
- Infinity Clinical Research, LLC
-
-
Michigan
-
Ann Arbor, Michigan, United States
- University of Michigan Health System
-
Farmington Hills, Michigan, United States
- Quest Research Institute
-
Grand Rapids, Michigan, United States
- Spectrum Health
-
-
Missouri
-
St. Louis, Missouri, United States
- Washington University
-
-
New York
-
Mineola, New York, United States, NY 11501
- Winthrop University Hospital Clinical Trials Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Temple University Hospital
-
-
South Carolina
-
Charleston, South Carolina, United States
- MUSC (Medical University of South Carolina)
-
-
Vermont
-
Burlington, Vermont, United States
- UVM MRI Center for Biomedical Imaging
-
-
Washington
-
Seattle, Washington, United States
- University of Washington Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dotarem®/Gadovist®
Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
|
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
|
Experimental: Gadovist®/Dotarem®
Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
|
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
Time Frame: Up to 15 days after randomization
|
Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion. |
Up to 15 days after randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kenneth Maravilla, MD, UNIVERSITY OF WASHINGTON MEDICAL CENTER, SEATTLE, USA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGD-44-058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Brain Tumor
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruitingBrain Tumor, Primary | Brain Tumor - MetastaticGermany
-
University of NebraskaRecruitingPrimary Brain Tumor | Metastatic Brain TumorUnited States
-
University of MiamiRecruitingGlioma | Brain Tumor | Malignant Glioma | Primary Brain Tumor | Malignant Primary Brain TumorUnited States
-
Washington University School of MedicineNot yet recruitingBrain Tumor, PrimaryUnited States
-
Pietro Mortini, MD, Prof.RecruitingBrain Tumor, Primary | Brain Tumor - MetastaticItaly
-
University of Michigan Rogel Cancer CenterTerminated
-
Shanghai Henlius BiotechRecruiting
-
National Cancer Institute (NCI)CompletedBrain Cancer | Brain Neoplasm | Brain Tumor, PrimaryUnited States
-
GuerbetRecruitingBrain Tumor, Recurrent | Brain Tumor, PrimaryItaly, Hungary, Poland
-
Duke UniversityTerminated
Clinical Trials on Dotarem®
-
BayerCompletedNeoplastic CNS LesionsItaly
-
University of ChicagoGuerbetCompletedBreast Cancer | Breast Neoplasms | Breast Diseases | Breast FibroadenomaUnited States
-
Vanderbilt University Medical CenterChildren's Hospital of Philadelphia; GuerbetCompletedMagnetic Resonance Imaging Contrast AgentsUnited States
-
Northwestern UniversityCompletedVascular DiseasesUnited States
-
Bracco Diagnostics, IncCompleted
-
Massachusetts General HospitalWithdrawnContrast Media AllergyUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Dipan ShahGuerbetUnknownCoronary Artery Disease | Cardiomyopathy
-
Massachusetts General HospitalWithdrawn
-
GuerbetCompletedPeripheral Arterial DiseaseFrance