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

November 17, 2017 updated by: Institut Bergonié

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

Benefit of MRI in pathological nipple discharge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
        • Contact:
          • Martine BOISSERIE-LACROIX, MD
        • Principal Investigator:
          • Martine BOISSERIE-LACROIX, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with pathological nipple discharge

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective cohort - MRI
Patients with pathological nipple discharge
Device: MRI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound.
Time Frame: At baseline
At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

Société d'Imagerie de la Femme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2013-IRM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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