Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Breast Tomosynthesis; Architectural Distortions

Treatments: Device: Digital Breast Tomosynthesis (DBT)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06373354

2023-0924

NCI-2024-03341 (Other Identifier)

Details and patient eligibility

About

To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.

Full description

Primary Objectives

- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.

Secondary Objectives

• The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
• Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing standard screening mammography.
• Ability to understand and sign consent.

Exclusion criteria

• Pregnant women.
• Women unable to consent.
• Male patients.

Trial design

100 participants in 1 patient group

Digital Breast Tomosynthesis (DBT)

Description:

Participants that agree to take part in this study, your standard follow-up imaging will be done using an FDA approved DBT system, but it will be different from the DBT system used for your routine screening. For example, if narrow-angle DBT was used for your routine screening, then you will have standard wide-angle DBT. If wide-angle DBT used for your routine screening, then you will have narrow-angle DBT. These images will be used for diagnosis and to help decide your further care.

Treatment:

Device: Digital Breast Tomosynthesis (DBT)