Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
- Conditions
- Architectural DistortionsBreast Tomosynthesis
- Registration Number
- NCT06373354
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Women undergoing standard screening mammography.
- Ability to understand and sign consent.
- Pregnant women.
- Women unable to consent.
- Male patients.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and adverse events (AEs) Through study completion; an average of 1 year ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center🇺🇸Houston, Texas, United StatesBeatriz Adrada, MDPrincipal Investigator