Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02819362
• Lead Sponsor: Institut Bergonié

Brief Summary

Benefit of MRI in pathological nipple discharge.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Primary Completion: 2016-12
• Study Completion: 2016-12-01
• Results First Submitted: 2025-08-22
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Results First Posted: 2025-10-15
• Last Update Posted: 2025-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Single pore nipple discharge neither green nor milky.
2. Mammography (at least 2 shots, +/- centred on retro-areal) normal.
3. Initial ultrasound: normal.
4. Age over 18 years
5. Female
6. Patient affiliated to the social security scheme.
7. Patient information and informed consent signed and dated

Exclusion Criteria

Physiological milky or green discharge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Negative Predictive Value (PVV) of MRI	At baseline	The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound.; The VPN is defined by the ratio: number of patients with a normal histological examination / number of patients with a normal MRI.

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France