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

Early Phase 1CompletedNCT00826488

Washington University School of Medicine136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Conditions

Fibrocystic Disease of Breast Breast Cancer

Interventions

Digital Breast TomosynthesisDEVICE

Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * 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 * Men * Women less than 35 years old * Women greater than 80 years old * Subjects whose breasts are larger than the tomosynthesis detector

Locations (1)

JoAnne Knight Breast Center, Barnes Hospital

St Louis, Missouri, United States

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

Data from ClinicalTrials.gov

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