Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Condition: Primary Brain Tumor
MeSH terms: Brain Neoplasms
Intervention: Dotarem®; Gadovist®/Gadavist®
Intervention description: Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.; Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary brain tumor

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.
    

Eligibility 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.