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

This study is currently recruiting participants.
Verified March 2013 by University of Michigan
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00859261
First received: March 9, 2009
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Breast Tumor
Breast Cysts
Breast Abnormalities
 Procedure: Experimental 3D Breast Ultrasound imaging
Procedure: Experimental Photoacoustic Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 2D Silicon Transducer-Compression Plates for Breast Ultrasound

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the quality of 3 D ultrasound in comparison to conventional mammography


Estimated Enrollment: 132
Study Start Date: March 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Evaluating 3D ultrasound for breast abnormalities/masses/cysts
 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)

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859261

Contacts
Contact: Paul Carson, Ph.D. 734-763-5884 pcarson@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jeanne Hill, CRA     734-647-9546     jemhill@umich.edu    
Principal Investigator: Paul Carson, Ph.D.            
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Paul Carson, Ph.D. University of Michigan Basic Science Division
  More Information

No publications provided

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, GE Global Research, 2R01CA091713, R01CA115267
Study First Received: March 9, 2009
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Breast Cyst
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases
Cysts

ClinicalTrials.gov processed this record on May 16, 2013