MedTrace Logo

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

NCT02034708 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2016-12-30

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Dotarem®

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

DRUG

Gadovist®/Gadavist®

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

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Kenneth Maravilla, MD · University of Washington Medical Center, Seattle, USA

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Colombia
  • Mexico
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034708 on ClinicalTrials.gov