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Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Imaging Diagnostic Systems.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589043
First Posted: January 9, 2008
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imaging Diagnostic Systems
  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
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: 600
Study Start Date: October 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: December 24, 2007
First Posted: January 9, 2008
Last Update Posted: August 25, 2015
Last Verified: August 2015