Status:
COMPLETED
Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Brain Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00907530
Start Date
September 1 2009
End Date
July 1 2011
Last Update
January 5 2012
Active Locations (1)
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1
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada