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

Primary Brain Tumor Clinical Trial

— REMIND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034708
• Other study ID #: DGD-44-058
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2014
• Last updated: November 24, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosMexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Colombia	Fundacion Abood Shaio	Bogota
Colombia	Fundacion Cardioinfantil Instituto de Cardiologia	Bogota
Colombia	Instituto Nacional de Cancerologia	Bogota
Colombia	Centro Medico Imbanaco	Cali
Colombia	Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM	Medellin
Colombia	Hospital Pablo Tobon Uribe	Medellin
Korea, Republic of	Chungbuk National University	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Chonbuk national Univ Hosp	Jeonju-si	Jeollabuk-do
Korea, Republic of	Asan medical center	Seoul	Songpa-Gu
Korea, Republic of	Seoul St.Mary Hospital	Seoul	Seocho-gu
Korea, Republic of	Ajou University Hospital	Suwon
Mexico	Hospital CIMA	Chihuahua
Mexico	Morales Vargas Centro de Investigación S.C.	Leon	Guanajuato
Mexico	Centro Neurologico ABC	Mexico	Mexico Distrito Federal
Mexico	Centro Regiomontano de Investigacion S.C.	Monterrey
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo Leon
Mexico	Winsett Rethman S.A. de C.V.	Monterrey	Nuevo León
Mexico	Clinical Research Institute S.C.	Tlanepantla
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UVM MRI Center for Biomedical Imaging	Burlington	Vermont
United States	MUSC (Medical University of South Carolina)	Charleston	South Carolina
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Winthrop University Hospital Clinical Trials Center	Mineola	New York
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Washington Medical Center	Seattle	Washington
United States	Washington University	St. Louis	Missouri
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Colombia,  Korea, Republic of,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall lesion visualization and characterization	Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, assessed by 3 independent off-site readers, based 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	No