NCT06373354

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Architectural Distortions
• Breast Tomosynthesis

Interventions

Type	Name	Description
DEVICE	Digital Breast Tomosynthesis (DBT)	Undergo tomosynthesis imaging

Timeline

• Start date: 2024-10-18
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-04-18
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study