A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hologic, Inc.
- Enrollment
- 240
- Primary Endpoint
- Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
Study Overview
Brief Summary
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Detailed Description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female, any ethnic origin
- •No contraindication for diagnostic mammography
Exclusion Criteria
- •Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
- •Under 30 years of age at the time of consent
- •Unable to understand and execute written informed consent
Outcomes
Primary Outcomes
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
Time Frame: 1 year
images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest
Secondary Outcomes
No secondary outcomes reported