Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts

Breast Neoplasms Clinical Trial

Official title: Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts

Status Completed

Clinical Trial Summary

Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.

Clinical Trial Description

1. Patients with dense breast will be examined for the detection of breast cancer by imaging studies.

2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.

3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.

4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT01910103
• Study type: Observational
• Source: Seoul National University Hospital
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: June 2014