PHASE IV, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSSOVER STUDY TO COMPARE 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® IN MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN (MERIT) - MERIT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Subject who:
• Are at least 18 years of age or older
• Are able to give written informed consent and are willing to comply with the protocol
requirements
• Are scheduled to undergo MRI
• Are willing to undergo two MRI procedures within 14 days
• Subjects who have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
- clinical/neurological symptomatology;
- diagnostic testing, such as CT or previous MRI examinations; or
- have had recent surgery within 6 months and are to be evaluated for recurrence.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who:
• Are pregnant or lactating females. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine ßHCG) within 24 h prior to the start of each investigational product administration
- by history (i.e., tubal ligation or hysterectomy)
- post menopausal with a minimum of 1 year without menses
• Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals
• Have congestive heart failure (class IV according to the classification of the New York Heart Association)
• Have suffered a stroke within a year
• Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2
• Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product.
• Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min.
• Have been previously entered into this study
• Have received or are scheduled for one of the following:
- Surgery within three weeks prior to the first examination or between the two examinations
- Initiation of steroid therapy between the two examinations
- Radiosurgery between the two examinations
• Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
• Are suffering from severe claustrophobia
• Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method