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NCT02818946 · ClinicalTrials.gov registry record · NA
Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02818946 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 30 participants.
The verdict
NCT02818946, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DEVICE MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-07 |
| Est. Completion | 2019-08-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02818946
The ClinicalTrials.gov registry entry for NCT02818946 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MRI is the first listed.
NCT02818946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02818946 about?
NCT02818946 is a clinical study titled "Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial". 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...
What is the current status of trial NCT02818946?
This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2016-07. Estimated completion is 2019-08-06.
What interventions are being tested in trial NCT02818946?
The interventions under investigation include: MRI (DEVICE).
Who is sponsoring clinical trial NCT02818946?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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