MD Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06373354
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.
Recruiting
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Request InfoKey information
Conditions
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Women undergoing standard screening mammography.
- Ability to understand and sign consent.
Exclusion criteria
- Pregnant women.
- Women unable to consent.
- Male patients.
Treatment and study plan
Digital Breast Tomosynthesis (DBT)
DeviceUndergo tomosynthesis imaging
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
M.D. Anderson Cancer Center
Other
Collaborators
- Siemens Medical Solutions
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 18, 2024
- Registry last updated
- May 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.