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| Name | Class |
|---|---|
| Société d'Imagerie de la Femme | OTHER |
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Benefit of MRI in pathological nipple discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort - MRI | Patients with pathological nipple discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
Physiological milky or green discharge
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Patients with pathological nipple discharge
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33846843 | Derived | Boisserie-Lacroix M, Doutriaux-Dumoulin I, Chopier J, Boyer B, Depetiteville MP, Hoppe S, Brouste V, Chamming's F. Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study. Eur Radiol. 2021 Oct;31(10):7783-7791. doi: 10.1007/s00330-021-07790-4. Epub 2021 Apr 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Population included in the study, satisfying eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | At baseline |
|
All-Cause Mortality, Serious and/or Other Adverse Events were not monitored/assessed in this study,
All-Cause Mortality, Serious and/or Other Adverse Events were not monitored/assessed in this study,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |