Computed Tomography Laser Mammography Breast Imaging Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Imaging Diagnostic Systems.
Recruitment status was  Recruiting
Information provided by:
Imaging Diagnostic Systems Identifier:
First received: December 24, 2007
Last updated: January 8, 2008
Last verified: December 2007

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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Computed Tomography Laser Mammography Breast Imaging Device Model 1020

Resource links provided by NLM:

Further study details as provided by Imaging Diagnostic Systems:

Estimated Enrollment: 1200
Study Start Date: April 2005

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heterogeneous or extremely dense breast patient population scheduled for biopsy


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00589043

Contact: Deborah O'Brien 954-581-9800

United States, Connecticut
Waterbury Hospital Health Center Recruiting
Waterbury, Connecticut, United States
Contact: Juana Clarke    203-573-6086   
Principal Investigator: Scott Kurtzman, MD         
Sponsors and Collaborators
Imaging Diagnostic Systems
Study Director: Deborah O'Brien Imaging Diagnostic Systems
  More Information

No publications provided

Responsible Party: Deborah O'Brien, Imaging Diagnostic Systems, Inc. Identifier: NCT00589043     History of Changes
Other Study ID Numbers: PMA080505, PMA080505
Study First Received: December 24, 2007
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration processed this record on August 02, 2015