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

NCT02818946 | Terminated Results DMC

• 1 other identifier: Pro00063806
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Nipple; Breast Neoplasms

Keywords

MRI; Spontaneous Nipple Discharge; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Sensitivity of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with negative MRIs who present within 1 year with breast cancer)\]

  Day 1

• Specificity

  Specificity of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with positive MRIs but with benign biopsy)\]

  Day 1

• Positive Predictive Value

  Positive Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with positive MRIs but with benign biopsy)\]

  Day 1

• Negative Predictive Value

  Negative Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with negative MRIs who present within 1 year with breast cancer)\]

  Day 1

Study Arms (1)

MRI

OTHER

Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.

Device: MRI

Interventions

MRI DEVICE

Detection of cancer by MRI for pathologic nipple discharge

MRI

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge
• clinical decision to have contrast enhanced MRI

You may not qualify if:

• male gender
• non-English speakers
• age \< 21 years
• lack of capacity to give legally effective consent

Sponsors & Collaborators

• Duke University: lead
• Bracco Diagnostics, Inc: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (18)

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  PMID: 18986790 BACKGROUND

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  PMID: 16551379 BACKGROUND

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  PMID: 17646365 BACKGROUND

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  PMID: 22211878 BACKGROUND

• Bahl M, Baker JA, Greenup RA, Ghate SV. Diagnostic Value of Ultrasound in Female Patients With Nipple Discharge. AJR Am J Roentgenol. 2015 Jul;205(1):203-8. doi: 10.2214/AJR.14.13354.

  PMID: 26102400 BACKGROUND

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  PMID: 18005783 BACKGROUND

• Morrogh M, Park A, Elkin EB, King TA. Lessons learned from 416 cases of nipple discharge of the breast. Am J Surg. 2010 Jul;200(1):73-80. doi: 10.1016/j.amjsurg.2009.06.021. Epub 2010 Jan 15.

  PMID: 20079481 BACKGROUND

• Orel SG, Dougherty CS, Reynolds C, Czerniecki BJ, Siegelman ES, Schnall MD. MR imaging in patients with nipple discharge: initial experience. Radiology. 2000 Jul;216(1):248-54. doi: 10.1148/radiology.216.1.r00jn28248.

  PMID: 10887256 BACKGROUND

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  PMID: 17896158 BACKGROUND

• Lubina N, Schedelbeck U, Roth A, Weng AM, Geissinger E, Honig A, Hahn D, Bley TA. 3.0 Tesla breast magnetic resonance imaging in patients with nipple discharge when mammography and ultrasound fail. Eur Radiol. 2015 May;25(5):1285-93. doi: 10.1007/s00330-014-3521-2. Epub 2014 Nov 30.

  PMID: 25433415 BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sujata Ghate, MD
• Organization: Duke University

sujata.ghate@duke.edu

919-684-2711

Study Officials

• Sujata Ghate, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: July 1, 2016
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)