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

• Conditions: Breast Cancer
• Interventions: Device: MRI

• 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
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

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

Arm && Interventions

Group	Intervention	Description
Prospective cohort - MRI	MRI	Patients with pathological nipple discharge

Primary Outcome Measures

Name	Time	Method
The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound.	At baseline

Secondary Outcome Measures

Name	Time	Method
Diagnostic performances of MRI (sensitivity, specificity, positive predictive value) in pathological nipple discharge with normal mammography / ultrasound.	At baseline

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France