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2D Silicon Transducer-Compression Plates for Breast Ultrasound


N/A
30 Years
80 Years
Open (Enrolling)
Female
Breast Tumor, Breast Cysts, Breast Abnormalities

Thank you

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 MichiganAnn Arbor, Michigan  48109-0624