LOUIS-3D Breast Study
This trial is active, not recruiting.
|Treatment||louis-3d imaging procedure|
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||TomoWave Laboratories, Inc.|
|Start date||May 2014|
|End date||May 2019|
|Trial size||96 participants|
|Trial identifier||NCT01755130, 2012-0210, NCI-2014-01243|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
LOUIS 3D Capability to Detect and Differentiate Breast Tumors
time frame: 1 day
Comparison of False Positive Rate of LOUIS-3D Compared to Ultrasound for Breast Cancer Detection
time frame: 1 day
Female participants from 20 years up to 85 years old.
- Mass palpable or nonpalpable
- Tissue density - all tissue types
- Menses - any stage of cycle
- Age between 20-85 inclusive
- Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion(s)).
- Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
- Any tumor type (patients with inflammatory breast cancer may be included).
- 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.
- Overweight over 250 LB
- Very large breast size exceeding 6 inch diameter
- 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 the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post bx change may be included).
- Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast.
- Patient has any pain or high sensitivity in the breast
- Currently taking hormonal replacement therapy
- Non-ambulatory or unable to comply with exam
- Pregnant (pregnancy test is not required, only as confirmed by patient).
- Prior breast treatment for target lesion
- Previous surgery of the breast in the last 3 months
|Official title||Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care|
|Principal investigator||Wei Yang, MD|
|Description||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.|
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