Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06373354
Enrollment
100
Registered
2024-04-18
Start date
2024-10-18
Completion date
2027-12-31
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Architectural Distortions, Breast Tomosynthesis

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.

Interventions

Undergo tomosynthesis imaging

Sponsors

Siemens Medical Solutions
CollaboratorINDUSTRY
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Safety and adverse events (AEs)Through study completion; an average of 1 yearncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

Countries

United States

Contacts

Primary ContactBeatriz Adrada, MD
beatriz.adrada@mdanderson.org(713) 792-2709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026