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OpenTrials
Completed

NCT Number: NCT01910103

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

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

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Radiology, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic performance (AUC: area of under ROC curve) of DBT and US

    Time frame: 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 outcomes

  1. Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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