Skip to main content
OpenTrials
Completed

NCT Number: NCT00859261

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Tumor Breast Cyst Breast Cysts Breast Diseases Breast Neoplasms Cysts Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Photoacoustic Tomography (PAT)

Primary outcomes

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2009
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.