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Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

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ClinicalTrials.gov Identifier: NCT00589043
Recruitment Status : Unknown
Verified August 2015 by Imaging Diagnostic Systems.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2008
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Breast Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Official Title: Computed Tomography Laser Mammography Breast Imaging Device Model 1020
Study Start Date : October 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
  • Protoporphyria
  • Lactating
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589043


Contacts
Contact: Debra Wood 954-581-9800 dwood@imds.com

Sponsors and Collaborators
Imaging Diagnostic Systems
Investigators
Study Chair: David Jin, MD Imaging Diagnostic Systems
More Information

Responsible Party: Imaging Diagnostic Systems
ClinicalTrials.gov Identifier: NCT00589043     History of Changes
Other Study ID Numbers: NA at present
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015