Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Architectural Distortions
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Safety and adverse events (AEs)
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women undergoing standard screening mammography.
- •Ability to understand and sign consent.
Exclusion Criteria
- •Pregnant women.
- •Women unable to consent.
- •Male patients.
Outcomes
Primary Outcomes
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events