The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- WellSpan Health
- Enrollment
- 690
- Primary Endpoint
- to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).
Study Overview
Brief Summary
There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 26 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •female of any race and ethnicity
- •35 years or older
- •after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
- •subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
- •female of any race and ethnicity
- •26 years or older
- •subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
- •subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
- •female of any race and ethnicity
- •26 years or older
- •subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
- •subject will undergo study imaging within 30 days of surveillance imaging
Exclusion Criteria
- •GROUP 1, 2 and 3
- •subjects unable or unwilling to participate
- •subjects who are unable or unwilling to tolerate compression
- •subjects who are pregnant or who think they may be pregnant
- •subjects who are breastfeeding
Outcomes
Primary Outcomes
to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported