Computed Tomography Laser Mammography Breast Imaging Device
- Conditions
- Breast Cancer
- Registration Number
- NCT00589043
- Lead Sponsor
- Imaging Diagnostic Systems
- Brief Summary
The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
- Female
- 21 and over
- Heterogeneously or extremely dense breast
- Schedule for biopsy
- Gave informed consent
Exclusion Criteria
- Mammogram not performed within the last 60 days
- Open lesions on the breast
- Previous breast biopsy within 60 days of the CTLM scan
- Surgical deformity of breasts
- Commercial Tattoos
- Protoporphyria
- Lactating
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method