Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound
IRM-sein
1 other identifier
observational
70
1 country
1
Brief Summary
Benefit of MRI in pathological nipple discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
October 15, 2025
CompletedOctober 15, 2025
September 1, 2025
2.7 years
June 28, 2016
August 22, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The Negative Predictive Value (PVV) of MRI
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.
At baseline
Study Arms (1)
Prospective cohort - MRI
Patients with pathological nipple discharge
Interventions
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.
Eligibility Criteria
Patients with pathological nipple discharge
You may qualify if:
- 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
You may not qualify if:
- Physiological milky or green discharge
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Bergoniélead
- Société d'Imagerie de la Femmecollaborator
Study Sites (1)
Institut Bergonié
Bordeaux, 33076, France
Related Publications (1)
Boisserie-Lacroix M, Doutriaux-Dumoulin I, Chopier J, Boyer B, Depetiteville MP, Hoppe S, Brouste V, Chamming's F. Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study. Eur Radiol. 2021 Oct;31(10):7783-7791. doi: 10.1007/s00330-021-07790-4. Epub 2021 Apr 13.
PMID: 33846843DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
- Organization
- Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
June 30, 2016
Study Start
April 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 15, 2025
Results First Posted
October 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share