Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2015 by Imaging Diagnostic Systems
Sponsor:
Information provided by (Responsible Party):
Imaging Diagnostic Systems
ClinicalTrials.gov Identifier:
NCT00589043
First received: December 24, 2007
Last updated: August 24, 2015
Last verified: August 2015
  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

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
  • Protoporphyria
  • Lactating
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Imaging Diagnostic Systems
ClinicalTrials.gov Identifier: NCT00589043     History of Changes
Other Study ID Numbers: NA at present
Study First Received: December 24, 2007
Last Updated: August 24, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2015