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

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.

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Key information

Conditions

Mammary Duct Ectasia of Unspecified Breast Breast Diseases Breast Neoplasms Female Mammographic Findings Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–90 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Identification of a solitary dilated breast duct at mammography

Exclusion criteria

Previous breast surgery at same side of detection of dilated duct

Treatment and study plan

Follow-up

Diagnostic Test

Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.

Ultrasound-guided percutaneous biopsy

Diagnostic Test

Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.

Primary outcomes

Abnormal histological finding at breast biopsy

Time frame: At guided-percutaneous biopsy

Detection of any histological abnormality

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Collaborators

Instituto Brasileiro de Controle do Cancer

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2019
First posted: May 19, 2017
Registry last updated: Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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