Is it possible to detect a fibrotic focus in a carcinoma with MR mammography with Gadovist 1.0 followed by core biopsy?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002135-33-BE

Enrollment

Registered

2008-05-06

Start date

2008-06-16

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast carcinoma

Interventions

Trade Name: Gadovist 15 ml Pharmaceutical Form: Solution for injection Trade Name: Gadovist 20 ml Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in whom clinical examination, mammography, ultrasound are suspicious for the presence of a malignant mass in the breast(s) will be included in the study 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: In addition to pregnant or lactating patients, patients under the age of 18 and patients with known or possible risks for allergic reactions/hypersensitivity - also patient groups which are at a higher risk for other adverse reactions, such as patients with severely impaired renal function, low threshold for seizures and severe cardiovascular disease are to excluded from the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if MR mammography using Gadovist together with core biopsy can diagnose a fibrotic focus (FF) in breast carcinoma. ;Secondary Objective: ;Primary end point(s): Can MR mammography using Gadovist 1.0 aid in the diagnosis of fibrotic focus in breast carcinoma?	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026