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

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer; Fibrocystic Disease of Breast

Treatments: Device: Digital Breast Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00826488

DBT11212008

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: Female

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

observational

Other group

Description:

Observational

Treatment:

Device: Digital Breast Tomosynthesis