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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
Sponsor:
Information provided by:
Imaging Diagnostic Systems
ClinicalTrials.gov Identifier:
NCT00589043
First received: December 24, 2007
Last updated: January 8, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by Imaging Diagnostic Systems:

Estimated Enrollment: 1200
Study Start Date: April 2005
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589043

Contacts
Contact: Deborah O'Brien 954-581-9800 OBrien@imds.com

Locations
United States, Connecticut
Waterbury Hospital Health Center Recruiting
Waterbury, Connecticut, United States
Contact: Juana Clarke     203-573-6086     jclarke1@wtbyhosp.org    
Principal Investigator: Scott Kurtzman, MD            
Sponsors and Collaborators
Imaging Diagnostic Systems
Investigators
Study Director: Deborah O'Brien Imaging Diagnostic Systems
  More Information

No publications provided

Responsible Party: Deborah O'Brien, Imaging Diagnostic Systems, Inc.
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013