Breast lesion detection and characterization at contrast-Enhanced MRI of the breast: comparison of gadoterate meglumine versus gadobenate dimeglumine at 3 Tesla

Med. Univ. Wien, Univ. Klinik für Radiodiagnostik0 sites130 target enrollmentMay 31, 2012

Overview

Phase: Phase 1
Intervention: Not specified
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.
Sponsor: Med. Univ. Wien, Univ. Klinik für Radiodiagnostik
Enrollment: 130
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

May 31, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Med. Univ. Wien, Univ. Klinik für Radiodiagnostik

•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.