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

Completed

• Conditions: Mammographic Findings; Female; Mammary Duct Ectasia of Unspecified Breast
• Interventions: Diagnostic Test: Ultrasound-guided percutaneous biopsy; Diagnostic Test: Follow-up

• Registration Number: NCT03161392
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-16
• Primary Completion: 2017-03-13
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Status Verified: 2019-07
• Study Completion: 2019-07-29
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• Identification of a solitary dilated breast duct at mammography

Read More

Exclusion Criteria

• Previous breast surgery at same side of detection of dilated duct

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ductal lesion	Ultrasound-guided percutaneous biopsy	Subjects with a ductal lesion detected on ultrasonography.
No ductal lesion	Follow-up	Subjects without a ductal lesion detected on ultrasonography

Primary Outcome Measures

Name	Time	Method
Abnormal histological finding at breast biopsy	At guided-percutaneous biopsy	Detection of any histological abnormality