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Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

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.
 
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):
Imaging Diagnostic Systems

Tracking Information
First Submitted Date December 24, 2007
First Posted Date January 9, 2008
Last Update Posted Date August 25, 2015
Study Start Date October 2015
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00589043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computed Tomography Laser Mammography Breast Imaging Device
Official Title Computed Tomography Laser Mammography Breast Imaging Device Model 1020
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Heterogeneous or extremely dense breast patient population scheduled for biopsy
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 24, 2015)
600
Original Estimated Enrollment
 (submitted: January 8, 2008)
1200
Estimated Study Completion Date November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00589043
Other Study ID Numbers NA at present
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Imaging Diagnostic Systems
Study Sponsor Imaging Diagnostic Systems
Collaborators Not Provided
Investigators
Study Chair: David Jin, MD Imaging Diagnostic Systems
PRS Account Imaging Diagnostic Systems
Verification Date August 2015