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Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial

NCT02818946 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-07

Study results available
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Summary

The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) and refer them for breast MRI. When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent patients to document the results and follow-up. The study team will not be obtaining MRI's on patients for research purposes only. The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation. Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality and unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a gadolinium-based contrast agent will be administered for the MRI, patients with compromised renal function and patients who are pregnant will be excluded from the study.

Conditions

  • Disorder of Nipple
  • Breast Neoplasms

Interventions

DEVICE

MRI

Detection of cancer by MRI for pathologic nipple discharge

Sponsors & Collaborators

Principal Investigators

  • Sujata Ghate, MD · Duke University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-08-06
Completion
2019-08-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818946 on ClinicalTrials.gov