Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain (MERIT)

Bracco

Status and phase

Completed

Phase 4

Conditions

Brain Lesions

Treatments

Drug: GADOVIST

Drug: MULTIHANCE:

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907530

MH-123

Details and patient eligibility

About

This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Enroll subjects in this study if they meet the following inclusion criteria:
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
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.

Exclusion criteria

Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
Are pregnant or lactating females. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine bHCG) 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