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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01910103

Enrollment

825

Registered

2013-07-29

Start date

2013-06-30

Completion date

2014-06-30

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms/radiography, Mammography/methods, Mass Screening, Tomography, X-Ray Computed/methods, Predictive Value of Tests, False Positive Reactions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results