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Computed Tomography Laser Mammography Breast Imaging Device Model 1020


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

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 CenterWaterbury, Connecticut