Actively Recruiting

FEMALE
ID06373354

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

Led by M.D. Anderson Cancer Center · Updated on 2026-05-04

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

S

Siemens Medical Solutions

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two types of digital breast tomosynthesis (DBT) systems: narrow-angle and wide-angle. The study focuses on evaluating which system provides better visibility of masses and architectural distortions in breast imaging. It also gathers feedback from radiologists, technologists, and participants regarding the imaging experience and comfort. Participants will receive follow-up imaging using an FDA-approved DBT system that differs from their routine screening system. For example, if their standard screening used narrow-angle DBT, the study imaging will use wide-angle DBT, and vice versa. These images will be used for diagnosis and to guide further care. Throughout the study, participants will be monitored for safety and any adverse events for about one year. Researchers will also collect radiologist feedback, technologist experiences, and participant comfort survey responses. The study involves women undergoing standard screening mammography who can provide informed consent.

CONDITIONS

Brief Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing standard screening mammography.
  • Ability to understand and sign consent.
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single imaging session

Participants undergo standard follow-up imaging using a digital breast tomosynthesis system different from their routine screening to compare image quality.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 1 year

Participants are monitored for safety and adverse events related to the imaging procedure.

Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Beatriz Adrada, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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