Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
If you agree to take part in this study, you will have the LOUIS-3D imaging procedure either
on the same day or within 10 days of a regular scheduled visit for a mammogram, ultrasound,
magnetic resonance imaging (MRI) scan, or any other breast imaging procedure, between 1 and
7 days before your scheduled biopsy. The results of the LOUIS-3D imaging scans will be
compared with the results of your other imaging scan(s).
For the LOUIS-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 LOUIS-3D procedure should take
about 30 minutes to complete.
Length of Study:
You will be off study after the LOUIS-3D imaging procedure is complete.
This is an investigational study. The LOUIS-3D device is not FDA approved or commercially
available. The use of the LOUIS-3D device to detect and monitor changes in breast tumors is
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 Capability to Detect and Differentiate Breast Tumors
The primary aim of this study is to successfully obtain images from LOUIS 3D and assess pathology in order to guide image calibration and gain knowledge about LOUIS 3D capabilities. Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.
Wei Yang, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|