Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound

University of Michigan

Status: Completed

Conditions: Breast Cysts; Breast Tumor

Treatments: Procedure: Experimental Photoacoustic Imaging; Procedure: Experimental 3D Breast Ultrasound imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00859261

HUM 15464

2R01CA091713 (U.S. NIH Grant/Contract)

R01CA115267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.

Full description

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.

Enrollment: 21 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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21 participants in 1 patient group

Breast imaging using Ultrasound and Photoacoustic

Experimental group

Description:

Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.

Treatment:

Procedure: Experimental 3D Breast Ultrasound imaging

Procedure: Experimental Photoacoustic Imaging