NCT02034708: REMIND

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

Completed Phase 4 Results posted Last updated 9 November 2016

What this trial tests

Phase 4 trial testing Dotarem® in Primary Brain Tumor in 279 participants. Completed in 1 September 2015.

Timeline

1 June 2014

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Guerbet
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	diagnostic
Enrollment	279
Start date	1 June 2014
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	32 locations across United States, Colombia, Mexico, South Korea

Drugs / interventions tested

• Dotarem®
• Gadovist®/Gadavist® — full drug profile →

Conditions studied

• Primary Brain Tumor — all drugs for Primary Brain Tumor →

Sponsor

Guerbet — full company profile →

Who can join

18 and older, any sex, with Primary Brain Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 vi

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Gadoterate Meglumine and Gadobutrol in the MRI Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study).
   Maravilla KR, San-Juan D, Kim SJ, Elizondo-Riojas G, et al · · 2017 · cited 18× · PMID 28663267 · DOI 10.3174/ajnr.a5316