2D Silicon Transducer-Compression Plates for Breast Ultrasound
30 Years
80 Years
Female
Breast Tumor, Breast Cysts, Breast Abnormalities
Trial Information
2D Silicon Transducer-Compression Plates for Breast Ultrasound
To assist in the developement of 3 dimensional breast ultrasound imaging and when possible
compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or
clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can
provide important information not found on mammograms or routine breast ultrasound.
Inclusion Criteria:
- Healthy women OR
- Women with suspected benign masses who may/or may not be going to biopsy
- Women with cysts where no biopsy is recommended
Exclusion Criteria:
- Women who are pregnant
- Women with breast implants
- Prisoners
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.
Outcome Description:
Assess the quality of 3 D ultrasound in comparison to conventional mammography
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Paul Carson, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Basic Science Division
Authority:
United States: Institutional Review Board
Study ID:
HUM 15464
NCT ID:
NCT00859261
Start Date:
March 2009
Completion Date:
March 2016
Related Keywords:
- Breast Tumor
- Breast Cysts
- Breast Abnormalities
- Congenital Abnormalities
- Breast Neoplasms
- Breast Cyst
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
