This trial is active, not recruiting.

Condition breast cancer
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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.
louis-3d imaging procedure x-ray
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.

Primary Outcomes

LOUIS 3D Capability to Detect and Differentiate Breast Tumors
time frame: 1 day

Secondary Outcomes

Comparison of False Positive Rate of LOUIS-3D Compared to Ultrasound for Breast Cancer Detection
time frame: 1 day

Eligibility Criteria

Female participants from 20 years up to 85 years old.

Inclusion Criteria: 1. Mass palpable or nonpalpable 2. Tissue density - all tissue types 3. Menses - any stage of cycle 4. Age between 20-85 inclusive 5. 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)). 6. Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall 7. Any tumor type (patients with inflammatory breast cancer may be included). Exclusion Criteria: 1. Patient is unable or unwilling to give informed consent for any reason 2. Disability (psychiatric, neurological or physical, which precludes examination) 3. Patient has tattoos on the region of interest. 4. Overweight over 250 LB 5. Very large breast size exceeding 6 inch diameter 6. Patient has body piercing jewelry through the nipple that cannot be removed. 7. 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). 8. Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast. 9. Patient has any pain or high sensitivity in the breast 10. Currently taking hormonal replacement therapy 11. Non-ambulatory or unable to comply with exam 12. Pregnant (pregnancy test is not required, only as confirmed by patient). 13. Breastfeeding 14. Prior breast treatment for target lesion 15. Previous surgery of the breast in the last 3 months

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.