Overview

This trial is active, not recruiting.

Conditions breast tumor, breast cysts
Treatments experimental 3d breast ultrasound imaging, experimental photoacoustic imaging
Sponsor University of Michigan
Collaborator National Institutes of Health (NIH)
Start date March 2009
End date February 2015
Trial size 21 participants
Trial identifier NCT00859261, 2R01CA091713, GE Global Research, HUM 15464, R01CA115267

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
Arm
(Experimental)
Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging.
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 Photoacoustic Tomography (PAT)
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 Outcomes

Measure
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.
time frame: 1 year

Eligibility Criteria

Female participants from 30 years up to 80 years old.

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

Additional Information

Official title 2D Silicon Transducer-Compression Plates for Breast Ultrasound
Principal investigator Paul Carson, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Michigan.