Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Breast Tomosynthesis (DBT).
- Who it may be relevant to
- Registry conditions: Architectural Distortions, Breast Tomosynthesis. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Digital Breast Tomosynthesis (DBT)
Undergo tomosynthesis imaging
Primary outcome measures
- Safety and adverse events (AEs) [Time frame: Through study completion; an average of 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06373354 · 2023-0924 · NCI-2024-03341