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

Sponsor

Faculdade de Medicina do ABC (Other)

Overall Status

Completed

CT.gov ID

NCT03161392

Collaborator

Instituto Brasileiro de Controle do Cancer (Other)

135

Enrollment

40.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mammary Duct Ectasia of Unspecified Breast Mammographic Findings Female	Diagnostic Test: Follow-up Diagnostic Test: Ultrasound-guided percutaneous biopsy

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 Design

Study Type:

Observational

Actual Enrollment :

135 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 16, 2016

Actual Primary Completion Date :

Mar 13, 2017

Actual Study Completion Date :

Jul 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Ductal lesion Subjects with a ductal lesion detected on ultrasonography.	Diagnostic Test: Ultrasound-guided percutaneous biopsy Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.
No ductal lesion Subjects without a ductal lesion detected on ultrasonography	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.

Arm

Intervention/Treatment

Ductal lesion

Subjects with a ductal lesion detected on ultrasonography.

Diagnostic Test: Ultrasound-guided percutaneous biopsy

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

No ductal lesion

Subjects without a ductal lesion detected on ultrasonography

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.

Outcome Measures

Primary Outcome Measures

Abnormal histological finding at breast biopsy [At guided-percutaneous biopsy]
Detection of any histological abnormality

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Identification of a solitary dilated breast duct at mammography

Exclusion Criteria:

Previous breast surgery at same side of detection of dilated duct

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Faculdade de Medicina do ABC
Instituto Brasileiro de Controle do Cancer

Investigators

Study Director: Luciano M Pompei, PhD, ABC Medicine School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luciano de Melo Pompei', Professor, Faculdade de Medicina do ABC

ClinicalTrials.gov Identifier:

NCT03161392

Other Study ID Numbers:

Ductoisolado_01

First Posted:

May 19, 2017

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luciano de Melo Pompei', Professor, Faculdade de Medicina do ABC

mammography

ductal ectasia

breast neoplasm/diagnostic imaging

mammary Glands, Human/pathology

female

Additional relevant MeSH terms:

Dilatation, Pathologic

Study Results

No Results Posted as of Jul 30, 2019