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

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT01910103
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-29
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 825

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

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Exclusion Criteria

• Had breast surgery
• Had breast core biopsy performed within the prior 6 months on the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Radiology, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of