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

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ClinicalTrials.gov Identifier: NCT00859261
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : May 5, 2016
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan

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

Condition or disease Intervention/treatment
Breast Tumor Breast Cysts Procedure: Experimental 3D Breast Ultrasound imaging Procedure: Experimental Photoacoustic 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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 : March 2009
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Photoacoustic Tomography (PAT)

Primary Outcome Measures :
  1. To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging. [ Time Frame: 1 year ]
    Assess the quality of 3 D ultrasound in comparison to conventional mammography

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859261

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Paul Carson, Ph.D. University of Michigan Basic Science Division

Responsible Party: Paul L. Carson Ph.D, Principal Investigator ( Ph.D ), University of Michigan
ClinicalTrials.gov Identifier: NCT00859261     History of Changes
Other Study ID Numbers: HUM 15464
2R01CA091713 ( U.S. NIH Grant/Contract )
R01CA115267 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Breast Cyst
Neoplasms by Site
Breast Diseases
Skin Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs