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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034708
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : October 25, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Guerbet

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 13, 2014
Results First Submitted Date  ICMJE September 2, 2016
Results First Posted Date  ICMJE October 25, 2016
Last Update Posted Date December 30, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
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 visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Overall lesion visualization and characterization [ 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, 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Official Title  ICMJE Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Brain Tumor
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Dotarem®/Gadovist®
    Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
    Interventions:
    • Drug: Dotarem®
    • Drug: Gadovist®/Gadavist®
  • Experimental: Gadovist®/Dotarem®
    Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
    Interventions:
    • Drug: Dotarem®
    • Drug: Gadovist®/Gadavist®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
279
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
270
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Korea, Republic of,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034708
Other Study ID Numbers  ICMJE DGD-44-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guerbet
Study Sponsor  ICMJE Guerbet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kenneth Maravilla, MD University of Washington Medical Center, Seattle, USA
PRS Account Guerbet
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP