Computed Tomography Laser Mammography Breast Imaging Device

This study is currently recruiting participants.

Verified by Imaging Diagnostic Systems, December 2007

Sponsored by:	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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer CT Scans Cancer Mammography

U.S. FDA Resources

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

Further study details as provided by Imaging Diagnostic Systems:

Biospecimen Retention: None Retained

Biospecimen Description:

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

Responsible Party:	Imaging Diagnostic Systems, Inc. ( Deborah O'Brien )
Study ID Numbers:	PMA080505, PMA080505
Study First Received:	December 24, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00589043
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 06, 2009