Breast Cancer
Conditions
Keywords
Breast cancer, tomosynthesis
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.
Interventions
DEVICEGenesis and Gemini
3 dimensional breast mammography system
DEVICEInvestigational 3D Mammography system
3 dimensional breast mammography system
Sponsors
Hologic, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed