A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities

Hologic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: 3D mammograpgy system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990483

09-02

Details and patient eligibility

About

The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.

Enrollment: 110 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is female of any race and ethnicity
• Subject is at least 40 years old
• The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
• Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
• Subject will undergo study imaging within 30 days of standard of care imaging

Exclusion criteria

• Patients who are pregnant or think they may be pregnant
• Patients who are breast feeding
• Subjects unable or unwilling to undergo informed consent
• Subjects with breast implants

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

3D investigational imaging

Experimental group

Description:

patients returning with an area of interest will undergo investigational 3D imaging in 2 modes of imaging to the breast of interest and compare to the subjects standard of care imaging

Treatment:

Device: 3D mammograpgy system