A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
- Conditions
- Breast Cancer
- Registration Number
- NCT00759447
- Lead Sponsor
- Hologic, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- Female, any ethnic origin
- No contraindication for diagnostic mammography
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design 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 Outcome Measures
Name Time Method