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

NCT06373354 | Recruiting FDA Device

• 2 other identifiers: 2023-0924NCI-2024-03341
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.

Conditions

Architectural Distortions; Breast Tomosynthesis

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

  Through study completion; an average of 1 year

Study Arms (1)

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.

Device: Digital Breast Tomosynthesis (DBT)

Interventions

Digital Breast Tomosynthesis (DBT) DEVICE

Undergo tomosynthesis imaging

Digital Breast Tomosynthesis (DBT)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Screening mammography population at MD Anderson

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Beatriz Adrada, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Adrada, MD

CONTACT

(713) 792-2709; beatriz.adrada@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)