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

Conditions

• Architectural Distortions
• Breast Tomosynthesis

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Digital Breast Tomosynthesis (DBT) — DEVICE
  Undergo tomosynthesis imaging

Study Details

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

Key Dates

First listed

Apr 18, 2024

Start date

Oct 18, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: 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 Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Beatriz Adrada, MD
  (713) 792-2709
  [email protected]

Locations (1)

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