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

NCT00859261 — Not applicable, Completed, 21 participants, University of Michigan

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2D Silicon Transducer-Compression Plates for Breast Ultrasound

Registry	NCT00859261
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: single, diagnostic
Enrollment	21 (Actual)
Sponsor	University of Michigan (Other); collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions	Breast Tumor, Breast Cysts
Interventions	Experimental 3D Breast Ultrasound imaging, Experimental Photoacoustic Imaging (Procedure)
Dates	start 2009-03-01, primary completion 2015-02-01, completion 2015-02-01, first posted 2009-03-11, last updated 2016-05-05
Locations	1 site in United States

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Breast imaging using Ultrasound and Photoacoustic	Experimental	Procedure: Experimental 3D Breast Ultrasound imaging; Procedure: Experimental Photoacoustic Imaging	Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.

Experimental 3D Breast Ultrasound imaging (Procedure): 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.
Experimental Photoacoustic Imaging (Procedure), also known as Photoacoustic Tomography (PAT): 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.

+Outcome measures

Primary outcomes

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

Sex: Female, ages: 30 Years to 80 Years, 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

+Locations (1)

Facility	City	Country	Status
University of Michigan	Ann Arbor, Michigan	United States

+Investigators

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

+Funding

NIH grants: R01CA091713, R01CA115267

My Notes

Public

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