LOUIS-3D Breast Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care|
- LOUIS 3D Capability to Detect and Differentiate Breast Tumors [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Comparison of False Positive Rate of LOUIS-3D Compared to Ultrasound for Breast Cancer Detection [ Time Frame: 1 day ] [ Designated as safety issue: No ]Secondary objective is to determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, ultrasound emission characteristics, detection probe, coupling medium characteristics, software and firmware, etc.), anatomical information (speed of sound image, acoustic attenuation image, acoustic scattering image), and functional information (total hemoglobin distribution [THb] / image of angiogenesis density, image of blood oxygen saturation [SO2], and image of water distribution). Continuous variables summarized using descriptive statistics such as mean, standard deviation, median and range. Categorical variables tabulated by frequencies and the corresponding percentages.
|Study Start Date:||May 2014|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
Experimental: LOUIS-3D Imaging Procedure
Part I Years 1-4: Years 1-4 to develop and calibrate the LOUIS-3D machine. The subject of this project is to successfully obtain diagnostic imaging of breast tumors with new imaging technology, laser Optoacoustic Tomography system.
Part 2 Year 5: Goal of part 2 to estimate and compare the false positive rate of LOUIS-3D compared to standard of care ultrasound. Patients will have had a positive standard of care ultrasound requiring a biopsy (gold standard). The LOUIS-3D images will be obtained within 7 days of the standard of care ultrasound.
Procedure: LOUIS-3D Imaging Procedure
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 scheduled biopsy. Results of the LOUIS-3D imaging scans compared with results of other imaging scan(s). Entire LOUIS-3D procedure should take about 30 minutes to complete.
Other Name: x-ray
If you agree to take part in this study, you will have the LOUISA-3D scan performed within 7 days (+/- 2 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 (+/- 2 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755130
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wei Yang, MD||M.D. Anderson Cancer Center|