EUCTR2011-005498-21-ATActive, not recruitingPhase 1
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 enrollmentStarted: May 31, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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