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

Tracking Information

First Received Date ^ICMJE

March 9, 2009

Last Updated Date

March 6, 2013

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging. [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00859261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Brief Summary

The study purpose is to help in the developement of 3 dimensional breast ultrasound 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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Condition ^ICMJE

Breast Tumor
Breast Cysts
Breast Abnormalities

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: 1

Evaluating 3D ultrasound for breast abnormalities/masses/cysts

Interventions:

Procedure: Experimental 3D Breast Ultrasound imaging
Procedure: Experimental Photoacoustic Imaging

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

132

Estimated Completion Date

March 2016

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Paul Carson, Ph.D.

734-763-5884

pcarson@umich.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00859261

Other Study ID Numbers ^ICMJE

HUM 15464, GE Global Research, 2R01CA091713, R01CA115267

Has Data Monitoring Committee

Yes

Responsible Party

Paul L. Carson Ph.D, University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Paul Carson, Ph.D.

University of Michigan Basic Science Division

Information Provided By

University of Michigan

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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