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

Recruiting

• Conditions: Architectural Distortions; Breast Tomosynthesis
• Interventions: Device: Digital Breast Tomosynthesis (DBT)

• 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.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital Breast Tomosynthesis (DBT)	Digital Breast Tomosynthesis (DBT)	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.

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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States