Breast Cancer
Conditions
Brief summary
Benefit of MRI in pathological nipple discharge.
Interventions
DEVICEMRI
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.
Sponsors
Société d'Imagerie de la Femme
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Single pore nipple discharge neither green nor milky. 2. Mammography (at least 2 shots, +/- centred on retro-areal) normal. 3. Initial ultrasound: normal. 4. Age over 18 years 5. Female 6. Patient affiliated to the social security scheme. 7. Patient information and informed consent signed and dated
Exclusion criteria
Physiological milky or green discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Negative Predictive Value (PVV) of MRI | At baseline | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | On-site MRI could not be performed | 70 |
Baseline characteristics
| Characteristic | Prospective Cohort - MRI | — |
|---|---|---|
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 70 participants | — |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Negative Predictive Value (PVV) of MRI
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.
Time frame: 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.