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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: Clinical Trial NA study, sponsored by Duke University.
NCT02818946 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sensitivity of MRI in detecting breast cancer in women with pathologic nipple discharge. \[Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with negative MRIs who present within 1 year with breast cancer)\]
Interventions
- DEVICE MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-07 |
| Est. Completion | 2019-08-06 |
| Phase | NA |
Why NCT02818946 stopped before completion
NCT02818946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which MRI is the first listed.
NCT02818946 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02818946's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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