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

2D Silicon Transducer-Compression Plates for Breast Ultrasound

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00859261
Enrollment
21
Registered
2009-03-11
Start date
2009-03-31
Completion date
2015-02-28
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cysts, Breast Tumor

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.

Interventions

PROCEDUREExperimental 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.

PROCEDUREExperimental 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.1 yearAssess the quality of 3 D ultrasound in comparison to conventional mammography

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026