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

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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