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

Benefit of MRI in pathological nipple discharge.

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut Bergonié

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Physiological milky or green discharge

Treatment and study plan

MRI

Device

The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.

Primary outcomes

The Negative Predictive Value (PVV) of MRI

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

Société d'Imagerie de la Femme

Registry information

Official study title

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

Acronym: IRM-sein

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 30, 2016
Registry last updated: Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed