Trial Information
Computed Tomography Laser Mammography Breast Imaging Device Model 1020
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
- Protoporhyria
- Lactating
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Principal Investigator
Deborah O'Brien
Investigator Role:
Study Director
Investigator Affiliation:
Imaging Diagnostic Systems
Authority:
United States: Food and Drug Administration
Study ID:
PMA080505
NCT ID:
NCT00589043
Start Date:
April 2005
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
Waterbury Hospital Health Center |
Waterbury, Connecticut |