We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721435
First Posted: July 24, 2008
Last Update Posted: January 24, 2017
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.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
July 22, 2008
July 24, 2008
January 24, 2017
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. ]
Not Provided
Complete list of historical versions of study NCT00721435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
183
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
Sexes Eligible for Study: 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 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
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
January 2017

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