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

Experimental 3D Breast Ultrasound 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.

Experimental Photoacoustic Imaging

Paul Carson, Ph.D.

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

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.

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

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Assess the quality of 3 D ultrasound in comparison to conventional mammography

National Institutes of Health (NIH)

National Cancer Institute (NCI)

University of Michigan

Principal Investigator ( Ph.D )

To simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses.

These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography.

Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.

X-ray and ultrasound imaging scanning

The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.

Photoacoustic imaging scans for breast cancer screening

Paul L Carson, PhD

This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:

1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)

2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:

1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.

2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.

Simulated Screening Study for Breast Imaging

Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging

To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.

To determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound	NCT00859261	Breast Tumor Breast Cysts	Experimental 3D... Experimental Ph...	30 Years - 80 Years	University of Michigan
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound	NCT00859261	Breast Tumor Breast Cysts	Experimental 3D... Experimental Ph...	30 Years - 80 Years	University of Michigan
Simulated Screening Study for Breast Imaging	NCT01807754	Breast Cysts Breast Tumors	X-ray and ultra... Photoacoustic i...	30 Years - 80 Years	University of Michigan

Spots Global Cancer Trial Database for breast cysts

Every month we try and update this database with for breast cysts cancer trials from around the world to help patients and their families find trials that might be right for them.
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