Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings

Study Overview
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Brief Summary
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Mammograms performed at the Diagnostic Imaging Department of the Instituto Brasileiro de Controle do Câncer (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy will be performed.

Detailed Description
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Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam. Methods: Mammograms performed at the Diagnostic Imaging Department of the Instituto Brasileiro de Controle do Câncer (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be included in the study. These patients will be recalled in order to be submitted to an ultrasonography directed to the mammographic finding. Patients who present lesions on ultrasonography will undergo method-guided percutaneous biopsy. Patients with ductal ectasia, without evident lesions, will be followed for 2 years to evaluate stability by means of mammography or ultrasonography every 6-month intervals.

Official Title
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Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.

Conditions
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Mammary Duct Ectasia of Unspecified Breast, Mammographic Findings, Female

Intervention / Treatment
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* Diagnostic Test: Follow-up
* Diagnostic Test: Ultrasound-guided percutaneous biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identification of a solitary dilated breast duct at mammography Exclusion Criteria: Previous breast surgery at same side of detection of dilated duct

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ductal lesion<br>Subjects with a ductal lesion detected on ultrasonography. | Diagnostic Test: Ultrasound-guided percutaneous biopsy<br>* Group Ductal lesion will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.<br>|
| No ductal lesion<br>Subjects without a ductal lesion detected on ultrasonography | Diagnostic Test: Follow-up<br>* Group No ductal lesion will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal histological finding at breast biopsy | Detection of any histological abnormality | At guided-percutaneous biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mammography, ductal ectasia, breast neoplasm/diagnostic imaging, mammary Glands, Human/pathology, female