Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721435
First received: July 22, 2008
Last updated: May 3, 2016
Last verified: May 2016

July 22, 2008
May 3, 2016
April 2002
December 2014   (final data collection date for primary outcome measure)
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position. [ Time Frame: To be determined later. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00721435 on ClinicalTrials.gov Archive Site
Not Provided
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Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
The study will evaluate and refine a breast screening and diagnosis device.
The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Mass Cystic
  • Benign Mass
Procedure: 3D Tomosynthesis and ultrasound imaging
3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue
  • Experimental: 3D Tomosynthesis & 3D Ultrasound for breast masses
    Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
    Intervention: Procedure: 3D Tomosynthesis and ultrasound imaging
  • Experimental: 3D Tomosynthesis/ 3D Ultrasound for healthy subjects
    Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
    Intervention: Procedure: 3D Tomosynthesis and ultrasound imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
October 2016
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To participate in this research study you must be a female over the age of 25
  • Have had a normal mammogram or are scheduled for a breast biopsy
  • Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.

Exclusion Criteria:

  • Male
  • Under the age of 25
  • Documented breast cancer
Female
25 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721435
HUM00045519 (2002-0584), R01CA091713
No
No
Not Provided
Paul L. Carson Ph.D, University of Michigan
University of Michigan
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Paul L Carson, PHD University of Michigan
University of Michigan
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP