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

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Tumor Breast Cysts	Procedure: Experimental 3D Breast Ultrasound imaging Procedure: Experimental Photoacoustic Imaging	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breast imaging using Ultrasound and Photoacoustic Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.	Procedure: Experimental 3D Breast Ultrasound imaging Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete. Procedure: Experimental Photoacoustic Imaging Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete. Other Names: Photoacoustic Tomography (PAT)

Arm

Intervention/Treatment

Experimental: Breast imaging using Ultrasound and Photoacoustic

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

Procedure: Experimental 3D Breast Ultrasound imaging

Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete.

Procedure: Experimental Photoacoustic Imaging

Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete.

Other Names:

Photoacoustic Tomography (PAT)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)

Investigators

Principal Investigator: Paul Carson, Ph.D., University of Michigan Basic Science Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul L. Carson Ph.D, Principal Investigator ( Ph.D ), University of Michigan

ClinicalTrials.gov Identifier:

NCT00859261

Other Study ID Numbers:

HUM 15464
2R01CA091713
R01CA115267

First Posted:

Mar 11, 2009

Last Update Posted:

May 5, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Breast Neoplasms

Breast Cyst

Study Results

No Results Posted as of May 5, 2016