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

Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161392
• Other study ID #: Ductoisolado_01
• Status: Completed
• Start date: March 16, 2016
• Est. completion date: July 29, 2019

Study information

• Verified date: July 2019
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 29, 2019
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Identification of a solitary dilated breast duct at mammography

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Female
• Mammary Duct Ectasia of Unspecified Breast
• Mammographic Findings
• Signs and Symptoms

Intervention

Diagnostic Test:
• Follow-up
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
Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC	Instituto Brasileiro de Controle do Cancer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal histological finding at breast biopsy	Detection of any histological abnormality	At guided-percutaneous biopsy