Primary and secondary brain tumors
Conditions
Sponsors
Knappschaftskrankenhaus Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to prove, that Gadovist® 1.0 provides superior contrast enhancement characteristics of primary and secondary brain tumors as compared to ProHance®, thereby providing superior information for further diagnostic and/ or therapeutic decisions;Secondary Objective: ;Primary end point(s): Overall assessment of contrast enhancement on a three-point scale (better, equal, worse) in a matched-pairs assessment from MR imaging examinations of all post-contrast T1-weighted images | — |
Countries
Germany
Outcome results
None listed