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

NCT00859261 | Completed DMC

• 3 other identifiers: HUM 154642R01CA091713R01CA115267
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Tumor; Breast Cysts

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Breast imaging using Ultrasound and Photoacoustic

EXPERIMENTAL

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

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

Interventions

Experimental 3D Breast Ultrasound imaging PROCEDURE

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.

Breast imaging using Ultrasound and Photoacoustic

Experimental Photoacoustic Imaging PROCEDURE

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.

Also known as: Photoacoustic Tomography (PAT)

Breast imaging using Ultrasound and Photoacoustic

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant
• Women with breast implants
• Prisoners

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Cyst

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cysts

Study Officials

• Paul Carson, Ph.D.

  University of Michigan Basic Science Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ( Ph.D )

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)