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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01910103

Collaborator

(none)

825

Enrollment

Location

Duration (Months)

68.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms

Detailed Description

Patients with dense breast will be examined for the detection of breast cancer by imaging studies.
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.
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.
The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.

Study Design

Study Type:

Observational

Actual Enrollment :

825 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

Diagnostic performance (AUC: area of under ROC curve) of DBT and US [one year]
The primary endpoint will be an analysis of the diagnostic performance of DBT to that of US for detecting breast cancer in the screening and diagnostic setting. The hypothesis is that DBT is not inferior to US for detecting breast cancer.

Secondary Outcome Measures

Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer. [One year]
We will calculate diagnostic sensitivity (%), sensitivity (%), negative predictive value (%), and positive predictive alue (%) of the DBT and US for the detection of breast cancer on a per-patient basis by using a BI-RADS score of 4 or 5 considered as test-positive and a BI-RADS score of 1, 2, or 3 considered as test-negative. Cases of women undergoing biopsy with malignant disease results were considered disease-positive. Cases of women with concordant benign biopsy results and women not undergoing biopsy with no evidence of breast malignancy after 1 year of clinical follow-up were considered diase-negative.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women aged at 20 years
Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms
Signed study-specific informed consent prior to registration