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

Breast Tumor Clinical Trial

Official title:

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859261
• Other study ID #: HUM 15464
• Secondary ID: 2R01CA091713R01C
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: May 3, 2016
• Start date: March 2009
• Est. completion date: February 2015

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cyst
• Breast Cysts
• Breast Neoplasms
• Breast Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year	No