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

Not Applicable

Completed

• Conditions: Breast Tumor; Breast Cysts
• Interventions: Procedure: Experimental 3D Breast Ultrasound imaging; Procedure: Experimental Photoacoustic Imaging

• Registration Number: NCT00859261
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast imaging using Ultrasound and Photoacoustic	Experimental 3D Breast Ultrasound imaging	Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.
Breast imaging using Ultrasound and Photoacoustic	Experimental Photoacoustic Imaging	Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.

Primary Outcome Measures

Name	Time	Method
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.	1 year	Assess the quality of 3 D ultrasound in comparison to conventional mammography

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States