Breast CancerIRM-seinNCT02819362

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

An observational study of Breast Cancer, run by Institut Bergonié at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Benefit of MRI in pathological nipple discharge. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: MRI
Type of treatment: Injection or infusion, Medical device
How many people: 70 participants
Where: 1 siteFrance
Study dates: Apr 2014to Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Patients with pathological nipple discharge

Who may be able to join

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

Who cannot join

Physiological milky or green discharge

Trial locations and contacts

1 site in 1 country.

France1 site

Institut Bergonié
Bordeaux, 33076

Other trials in France

About this study

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

Benefit of MRI in pathological nipple discharge.

Conditions: Breast Cancer
Being tested: MRI
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRIDevice
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.

Study groups in NCT02819362
Study group	Role	What they receive
Prospective cohort - MRI		Patients with pathological nipple discharge Receives: Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Dec 2016

First posted30 Jun 2016 (estimated)
Study startApr 2014
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819362
Sponsor's protocol ID: IB2013-IRM
Acronym: IRM-sein
Status last verified: Sep 2025
First submitted: 28 Jun 2016
Last updated: 15 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33846843

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound.
ClinicalTrials.gov ID: NCT02819362
Acronym / sponsor ID: IRM-sein / IB2013-IRM
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Institut BergoniéUniversity, hospital or other
Collaborators: Société d'Imagerie de la Femme
Study start: Apr 2014 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 15 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Benefit of MRI in pathological nipple discharge.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Prospective cohort - MRI	–	Device: MRIPatients with pathological nipple discharge

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with pathological nipple discharge

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Physiological milky or green discharge

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MRIThe 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.	Device	Prospective cohort - MRI

Primary outcome

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.

Results and safety

Results posted to the registry on 15 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prospective Cohort - MRI	70	0

Primary outcome: The Negative Predictive Value (PVV) of MRI

Time frame: At baseline

Population analysed: MRI could not performed as expected (technical problems with the machine - unrelated to the participants or the study). thus MRI data could not be collected, and as such, primary outcome could not be assessed.

Adverse events

Time frame: All-Cause Mortality, Serious and/or Other Adverse Events were not monitored/assessed in this study,. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prospective Cohort - MRI	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33846843Boisserie-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.
Individual participant dataSharing planned: No

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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Institut Bergonié at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Negative Predictive Value (PVV) of MRI (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02819362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.