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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibrocystic Disease of Breast Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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observational

Observational

Group Type OTHER

Digital Breast Tomosynthesis

Intervention Type DEVICE

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.

Interventions

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Digital Breast Tomosynthesis

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No