Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

Imaging Diagnostic Systems

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00589043

NA at present

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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