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Trial Outcomes & Findings for Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial (NCT NCT02818946)

NCT ID: NCT02818946

Last Updated: 2020-01-07

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Day 1

Results posted on

2020-01-07

Participant Flow

Participant milestones

Participant milestones
Measure
Contrast-enhanced MRI for Evaluation of Nipple Discharge
Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge. MRI: Detection of cancer by MRI for pathologic nipple discharge
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Contrast-enhanced MRI for Evaluation of Nipple Discharge
n=30 Participants
Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge. MRI: Detection of cancer by MRI for pathologic nipple discharge
Age, Customized
50-59 years
30 Participants
n=5 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
30 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Data not collected.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1

Population: Data not collected.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1

Population: Data not collected.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1

Population: Data not collected.

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

Outcome measures

Outcome data not reported

Adverse Events

Contrast-enhanced MRI for Evaluation of Nipple Discharge

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sujata Ghate, MD

Duke University

Phone: 919-684-2711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place