Multihance versus Dotarem at 3 Tesla
- Conditions
- the aim of this study is to intraindividually compare the use of equivalent doses of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, France) for breast MR imaging by using a prospective study design, evaluated independently by blinded readers.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2011-005498-21-AT
- Lead Sponsor
- Med. Univ. Wien, Univ. Klinik für Radiodiagnostik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 130
Patients with mammographycally and/or sonographically detected abnormalities classified as category BI-RADS 4 or 5 will be enrolled in this prospective study. All enrolled patients will provide written informed consent for both the study and the following elaboration of data.
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 will be excluded from the study if they are younger than 18 years old; are high risk patients; are pregnant or lactating; have a confirmed breast malignancy ; or are undergoing radiation therapy, chemotherapy or anticancer hormonal therapy for a known cancer, or if they received any other MR contrast agent during the 48 hours before the contrsat agent administration in our study. Patients who have any contraindications for MR examinations (eg, pacemaker, metallic implants) or with a history of hypersensitivity to gadolinium chelates will also be excluded from the 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