patients with cerebral neoplastic lesions MedDRA version: 6.1 Level: PT Classification code 10006131
Conditions
Interventions
Trade Name: GADOVIST
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadobutrolo
CAS Number: 138071-082-0
Concentration
Sponsors
BAYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult (> 18 years of age) patients (men or women of any ethnic group) with known cerebral intra and extra axial neoplastic lesions (primitive and secondary enhancing lesions) who are scheduled for CE-MRI for diagnostic work-up. 2.Patients must be willing and able to continue study participation following administration of Gd-D3A-Butrol and Gd-DOTA to ensure completion of all procedures and observations required by the study. 3.Fully informed and signed consent must be obtained from each patient. 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: 1.Patients who have received any investigational drug within the 30 days prior to entering this study. 2.Pregnant or lactating women. 3.Patients who have any contraindication to MRI examination. 4.Patients with renal insufficiency and eGFR < 30 ml/min/1.73m2 (to be documented) 5.Patients who have received any contrast material in the 24 hours prior to Gd-D3A-Butrol or Gd-DOTA injection, or who are scheduled to receive any contrast material within 24 hours afterwards. 6.Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery). 7.Patients who are scheduled for, or are likely to require, any surgery within 24 hours after the last MRI test procedure as well as patients who are either scheduled for or have undergone such therapy between the two MR scans. 8.Patients who have undergone local or systemic SNC tumor therapy within 2 weeks before the first MR scans as well as patients who are either scheduled for or have undergone such therapy between the two MR scans. 9.Patients with a history of allergoid or anaphylactoid reaction to any allergen including drugs and contrast agents. 10. Patients with metallic implants have to be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of MRI imaging with Gd-DOTA (Gadoterate meglumine; Dotarem, Guerbet, Roissy CdG Cedex, France) and Gadobutrol (Gadovist, Bayer Schering Pharma AG, Berlin, Germany) in patients with cerebral neoplastic lesions in terms of qualitative evaluation of lesion enhancement;Secondary Objective: Quantitative evaluation (by signal intensity of enhancement). Also safety will be evaluated as secondary end point.;Primary end point(s): | — |
Countries
Italy
Outcome results
None listed