Intra-individual, randomized comparison of the MRI contrast agents gadobutrol versus gadoterate meglumine in breast MR imaging - Gadovist in breast MRI
- Conditions
- Breast tumorMedDRA version: 9.1Level: LLTClassification code 10006192Term: Breast cancer NOS
- Registration Number
- EUCTR2009-013432-20-DE
- Lead Sponsor
- Charité Campus Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 52
•Age: 18-70 years
•female
•histologically proven breast tumor or suspected benign and malignant lesions, biopsy performed or planned
•willing to undergo all study procedures
•having personally signed and dated the informed consent form
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 are in (or are suspected of) pregnancy or nursery. In women of child bearing potential a pregnancy test must be performed before inclusion in this study
•Patients with any physical or mental status that interferes with the signing of informed consent
•any contraindication for MRI
•having received any contrast material within 12 hours prior to injection with study or comparator drug.
•requiring emergency treatment
•Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault or MDRD formula. Calculation of the clearance must be done before begin of study.
•Patients who are scheduled for breast surgery or who would have a biopsy prior to the second planned injection of contrast medium
•History of anaphylactoid or anaphylactic reaction to any contrast media
•Having been previously enrolled in this study
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