Do some calling about this and you will find the information needed to proceed. I did...Just because it isn't written, doesn't mean it isn't public knowledge. An application process is public knowledge, but not every strict detail is sent in a P.R.
Waterbury Hospital Health Center, Connecticut, USA
Estimated Enrollment: 1200
this is just one place.. in USA FLORIDA UNIVERSITY AS WELL.. FOR INTERNATIONALly 13,000 PEOPLE TESTED
First Received on December 24, 2007. Last Updated on January 8, 2008 History of Changes Sponsor: Imaging Diagnostic Systems Information provided by: Imaging Diagnostic Systems ClinicalTrials.gov Identifier: NCT00589043 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:
Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer CT Scans Cancer Mammography 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
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 June 18, 2012
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