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Computed Tomography Laser Mammography Breast Imaging Device
Conditions
Breast Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
Criteria: 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
- 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
Location
Waterbury Hospital Health Center
Waterbury, Connecticut, United States
Status: Recruiting
Contact: Juana Clarke - 203-573-6086 - jclarke1@wtbyhosp.org
Start Date
April 2005
Sponsors
Imaging Diagnostic Systems
Source
Imaging Diagnostic Systems
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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