LOUIS-3D Breast Study
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Purpose
The goal of this clinical research study is to learn if an imaging device called the Laser Optoacoustic Ultrasonic Imaging System (LOUIS-3D) is effective in detecting and monitoring changes in breast tumors.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: LOUIS-3D Imaging Procedure |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2013 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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 investigational.
Up to 96 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mass palpable or nonpalpable
- Tissue density - all tissue types
- Menses - any stage of cycle
- Age between 20-70 inclusive
- Breast size within specified size (e.g. B, C or D cup as appropriate per a fitting device)
- BIRADS category 4 or 5 as defined based on mammography and breast ultrasound indicating need for biopsy
- Tumor location - not in close proximity of chest wall (must be at least 10 mm from the chest wall)
- Index tumor size is no more than 2 centimeters
- Any tumor type (patients with inflammatory breast cancer may be included).
Exclusion Criteria:
- Patient is unable or unwilling to give informed consent for any reason
- Disability (psychiatric, neurological or physical, which precludes examination)
- Patient has tattoos on the region of interest.
- Patient has body piercing jewelry through the nipple that cannot be removed.
- Patient has had a core or excisional biopsy in the ipsilateral breast within 3 months (patients with previous fine needle aspirations but no US evidence of hematoma or post bx change may be included).
- Patient has inflammatory skin disease (i.e., psoriasis, eczema) affecting the breast.
- Currently taking hormonal replacement therapy
- Non-ambulatory or unable to comply with exam
- Weight in excess of exam table limits of 230 LB
- Prior biopsy clips present
- Implants present
- Pregnancy at 6 weeks or later when position on the stomach is not recommended or difficult (pregnancy test till not be required).
- Breastfeeding
- Previous breast radiation or surgery
Contacts and Locations| Contact: Wei Yang, MD | 713-563-0127 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Wei Yang, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01755130 History of Changes |
| Other Study ID Numbers: | 2012-0210 |
| Study First Received: | December 18, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer LOUIS-3D Breast Study x-ray Multimode Laser Optoacoustic Ultrasonic Tomography System |
Mass palpable or nonpalpable Breast lesions Ductal carcinomas Lobular carcinomas Fibroadenomas |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013