Intra-individual, randomized comparison of the MRI contrast agents Gadovist® 1.0 versus Prohance® in patients with primary and secondary brain tumors, evaluated in a blinded read
- Conditions
- Primary and secondary brain tumors
- Registration Number
- EUCTR2007-002888-27-DE
- Lead Sponsor
- Knappschaftskrankenhaus Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Patients (> 18 yrs) with known CNS lesion(s) indicated for contrast enhanced MRI for diagnosis and are scheduled for neurosurgical treatment
•Patients who are willing to undergo study procedures
•Patients who are willing and able to sign informed consent
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
•Patients who have previously entered this study
•Patients who are or are suspected in pregnancy or nursery
•Patients with any physical or mental status that interferes with the signing of informed consent
•Patients with a contraindication for MRI
•Patients who have received any contrast material in 12 hours prior to injection with study or comparator drug in combination with moderate or severe renal impairment.
•Patients who require emergency treatment
•Patients with severely impaired hepatic or renal functions (e.g. SGPT ? 2 times the upper limit of reference range, acute renal failure)
•Patients with underlying disease or concomitant medication which may interfere with efficacy evaluation
•Patients who are scheduled for CNS surgery or who would have a biopsy prior to the second planned injection of contrast medium
•Patients with known anaphylactoid or anaphylactic reaction to any contrast media
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