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

Primary Purpose

Breast Tumor, Breast Cysts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental 3D Breast Ultrasound imaging

Experimental Photoacoustic Imaging

About this trial

This is an interventional diagnostic trial for Breast Tumor

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast imaging using Ultrasound and Photoacoustic

Arm Description

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

Outcomes

Primary Outcome Measures

To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00859261

First Posted

March 9, 2009

Last Updated

May 3, 2016

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00859261

Brief Title

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

Official Title

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Tumor, Breast Cysts

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breast imaging using Ultrasound and Photoacoustic

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Experimental 3D Breast Ultrasound imaging

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Experimental Photoacoustic Imaging

Other Intervention Name(s)

Photoacoustic Tomography (PAT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.

Description

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

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Carson, Ph.D.

Organizational Affiliation

University of Michigan Basic Science Division

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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