Trial Outcomes & Findings for Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound (NCT NCT02819362)

Results Overview

The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound. The VPN is defined by the ratio: number of patients with a normal histological examination / number of patients with a normal MRI.

Recruitment status

COMPLETED

Target enrollment

70 participants

Primary outcome timeframe

At baseline

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Prospective Cohort - MRI Patients with pathological nipple discharge MRI: The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.
Overall Study STARTED	70
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Prospective Cohort - MRI Patients with pathological nipple discharge MRI: The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.
Overall Study On-site MRI could not be performed	70

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Cohort - MRI n=70 Participants Patients with pathological nipple discharge MRI: The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.
Age, Continuous	60 years n=70 Participants
Sex: Female, Male Female	70 Participants n=70 Participants
Sex: Female, Male Male	0 Participants n=70 Participants
Region of Enrollment France	70 participants n=70 Participants

PRIMARY outcome

Timeframe: At baseline

Population: MRI could not performed as expected (technical problems with the machine - unrelated to the participants or the study). thus MRI data could not be collected, and as such, primary outcome could not be assessed.

The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound. The VPN is defined by the ratio: number of patients with a normal histological examination / number of patients with a normal MRI.

Outcome measures

Outcome data not reported

Adverse Events

Prospective Cohort - MRI

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

Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place