Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound
NCT ID: NCT00859261
Last Updated: 2016-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2009-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Breast imaging using Ultrasound and Photoacoustic
Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with breast implants
* Prisoners
30 Years
80 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
University of Michigan
OTHER
Responsible Party
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Paul L. Carson Ph.D
Principal Investigator ( Ph.D )
Principal Investigators
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Paul Carson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Basic Science Division
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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