NCT02034708

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

Geographic Reach
4 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 25, 2016

Completed
Last Updated

December 30, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

January 10, 2014

Results QC Date

September 2, 2016

Last Update Submit

November 9, 2016

Conditions

Primary Brain Tumor

Keywords

Primary brain tumor

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent

    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

Study Arms (2)

Dotarem®/Gadovist®

EXPERIMENTAL

Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI

Drug: Dotarem®Drug: Gadovist®/Gadavist®

Gadovist®/Dotarem®

EXPERIMENTAL

Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI

Drug: Dotarem®Drug: Gadovist®/Gadavist®

Interventions

Dotarem®DRUG

Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.

Dotarem®/Gadovist®Gadovist®/Dotarem®
Gadovist®/Gadavist®DRUG

Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.

Dotarem®/Gadovist®Gadovist®/Dotarem®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

University of Arizona Medical Center

Tucson, Arizona, AZ 85724, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, United States

Location

Infinity Clinical Research, LLC

Hollywood, Florida, FL 33021, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, United States

Location

Quest Research Institute

Farmington Hills, Michigan, United States

Location

Spectrum Health

Grand Rapids, Michigan, United States

Location

Washington University

St Louis, Missouri, United States

Location

Winthrop University Hospital Clinical Trials Center

Mineola, New York, NY 11501, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, United States

Location

MUSC (Medical University of South Carolina)

Charleston, South Carolina, United States

Location

UVM MRI Center for Biomedical Imaging

Burlington, Vermont, United States

Location

University of Washington Medical Center

Seattle, Washington, United States

Location

Fundacion Abood Shaio

Bogotá, Colombia

Location

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, Colombia

Location

Instituto Nacional de Cancerologia

Bogotá, Colombia

Location

Centro Medico Imbanaco

Cali, Colombia

Location

Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM

Medellín, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Colombia

Location

Hospital CIMA

Chihuahua City, Chihuahua, 31238, Mexico

Location

Morales Vargas Centro de Investigación S.C.

León, Guanajuato, 37000, Mexico

Location

Centro Neurologico ABC

México, Mexico Distrito Federal, 5300, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64020, Mexico

Location

Winsett Rethman S.A. de C.V.

Monterrey, Nuevo León, Mexico

Location

Centro Regiomontano de Investigacion S.C.

Monterrey, Mexico

Location

Clinical Research Institute S.C.

Tlanepantla, Mexico

Location

Chonbuk national Univ Hosp

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Chungbuk National University

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

Seoul St.Mary Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

Asan medical center

Seoul, Songpa-Gu, 138-736, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical
Organization
Guerbet
corinne.dubourdieu@guerbet-group.com
+33 (0) 1 45 91 51 84

Study Officials

  • Kenneth Maravilla, MD

    University of Washington Medical Center, Seattle, USA

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 13, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 30, 2016

Results First Posted

October 25, 2016

Record last verified: 2016-11

Locations

ME(7)KR(5)CO(6)US(14)