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

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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

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.


Condition or disease Intervention/treatment Phase
Primary Brain Tumor Drug: Dotarem® Drug: Gadovist®/Gadavist® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : June 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Dotarem®/Gadovist®
Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
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.

Experimental: Gadovist®/Dotarem®
Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
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.




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034708


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Sponsors and Collaborators
Guerbet
Investigators
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Study Chair: Kenneth Maravilla, MD University of Washington Medical Center, Seattle, USA

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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT02034708     History of Changes
Other Study ID Numbers: DGD-44-058
First Posted: January 13, 2014    Key Record Dates
Results First Posted: October 25, 2016
Last Update Posted: December 30, 2016
Last Verified: November 2016

Keywords provided by Guerbet:
Primary brain tumor

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases