A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

Washington University School of Medicine1 site in 1 country136 target enrollmentMarch 2009

ConditionsFibrocystic Disease of Breast Breast Cancer

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Fibrocystic Disease of Breast
Sponsor: Washington University School of Medicine
Enrollment: 136
Locations: 1
Primary Endpoint: It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Principal Investigator

Darlene Bird, R.T. (M)

Research Coordinator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

•Any race or ethnicity
•At least 35 years old
•Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria

•Unable or unwilling to undergo informed consent
•Subjects who have breast implants
•Subjects who are unable or unwilling to tolerate compression
•Subjects who are pregnant or who think they may be pregnant
•Subjects who are currently lactating
•Women less than 35 years old
•Women greater than 80 years old
•Subjects whose breasts are larger than the tomosynthesis detector

Outcomes

Primary Outcomes

It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.

Time Frame: 9 months