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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

Purpose of the Study:

The purpose of this prospective study is to determine the diagnostic value of Magnetic Resonance Imaging (MRI) for the evaluation of patients with pathologic nipple discharge.

Background & Significance:

Nipple discharge, one of the most common reasons for referral to the breast imaging service, is often investigated by diagnostic mammography and sonography to evaluate for an underlying malignancy, the reported incidence of which ranges from 3 to 29%. If conventional imaging is negative, the patient may obtain further imaging with MRI, undergo ductography or ductoscopy, proceed to duct exploration and excision, or be observed. Findings on breast MRI, in addition to the patient's symptomatology (frequency and volume of discharge) and risk of breast cancer, are used to inform the decision about whether to pursue surgery or watchful waiting.

Limited research suggests that MRI may have a role in the evaluation of patients with nipple discharge because of its ability to identify mammographically- and sonographically-occult disease and to guide surgical excision. Previous research has drawn conclusions from small retrospective patient cohorts, and there is relatively wide variability in the reported diagnostic utility of MRI. Consequently, duct exploration and excision remains the gold standard diagnostic approach. However, duct excision is an invasive procedure that can be technically challenging, especially if the affected duct cannot be localized or if the intraductal lesion is located far posteriorly in the breast, and can result in complications, such as interruption of the neurovascular supply to the nipple-areolar complex, cosmetic deformity, and breastfeeding limitations.

  • Sensitivity [ Time Frame: Day 1 ]
    Sensitivity of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with negative MRIs who present within 1 year with breast cancer)]
  • Specificity [ Time Frame: Day 1 ]
    Specificity of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with positive MRIs but with benign biopsy)]
  • Positive predictive value [ Time Frame: Day 1 ]
    Positive Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with positive MRIs but with benign biopsy)]
  • Negative predictive value [ Time Frame: Day 1 ]
    Negative Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with negative MRIs who present within 1 year with breast cancer)]


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Duke University

    Dates:
    Date Received: June 28, 2016
    Date Started: July 2016
    Date Completion: June 2018
    Last Updated: June 28, 2016
    Last Verified: June 2016