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The goal of this clinical research study is to learn if an imaging device called the Laser Optoacoustic and Ultrasonic Imaging System Assembly (LOUISA-3D) is effective in detecting and monitoring changes in breast tumors.
If you agree to take part in this study, you will have the LOUISA-3D scan performed within 7 days after you have mammography or ultrasound scans.
If you have a routine biopsy scheduled, the LOUISA-3D scan will be performed within 7 days before that biopsy.
For the LOUISA-3D procedure, you will lay down on a specially-designed breast exam table and you will place your breast in a bowl-like imaging cup. The imaging cup will be filled with a gel that will help send signals to the imaging machine.
The procedure will produce 2 types of images. For the first type, the imaging cup will deliver light from a laser that will travel into your breast and tumor. The light is designed to detect acoustic waves which produce an image. Even though all light will be contained in the imaging cup, you will wear laser safety goggles during the procedure.
For the second type of image, the imaging cup will deliver an ultrasound to your breast which will produce an ultrasound image.
During the scans, the imaging cup will rotate around the breast to create 3-dimensional pictures. The scans may be repeated several times. The entire LOUISA-3D procedure should take about 30 minutes to complete.
Length of Study:
You will be off study after the LOUISA-3D imaging procedure is complete.
This is an investigational study. The LOUISA-3D device is not FDA approved or commercially available. The use of the LOUISA-3D device to detect and monitor changes in breast tumors is investigational.
Up to 96 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
LOUIS-3D Imaging Procedure
University of Texas MD Anderson Cancer Center
Active, not recruiting
M.D. Anderson Cancer Center
Published on BioPortfolio: 2015-05-12T18:23:23-0400
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