Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain
- Registration Number
- NCT00907530
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GADOVIST GADOVIST gadobutrol
- Primary Outcome Measures
Name Time Method To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets). Day 1 and Day 2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada