Clinical trial NCT02034708: Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Official title: Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Brain Tumor
Keywords: Primary brain tumor
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
timeFrame: Up to 15 days after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Mineola
country: United States
facility: Winthrop University Hospital Clinical Trials Center
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC (Medical University of South Carolina)
state: South Carolina
city: Burlington
country: United States
facility: UVM MRI Center for Biomedical Imaging
state: Vermont
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Bogota
country: Colombia
facility: Fundacion Abood Shaio
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil Instituto de Cardiologia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Medellin
country: Colombia
facility: Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University
state: Chungcheongbuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk national Univ Hosp
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary Hospital
state: Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Songpa-Gu
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigación S.C.
state: Guanajuato
city: Mexico
country: Mexico
facility: Centro Neurologico ABC
state: Mexico Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Winsett Rethman S.A. de C.V.
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Hospital CIMA
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigacion S.C.
city: Tlanepantla
country: Mexico
facility: Clinical Research Institute S.C.
Study officials:
affiliation: University of Washington Medical Center, Seattle, USA
name: Kenneth Maravilla, MD
role: STUDY_CHAIR
References: