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Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care

20 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

1. Mass palpable or nonpalpable

2. Tissue density - all tissue types

3. Menses - any stage of cycle

4. Age between 20-70 inclusive

5. Breast size within specified size (e.g. B, C or D cup as appropriate per a fitting

6. BIRADS category 4 or 5 as defined based on mammography and breast ultrasound
indicating need for biopsy

7. Tumor location - not in close proximity of chest wall (must be at least 10 mm from
the chest wall)

8. Index tumor size is no more than 2 centimeters

9. 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. Patient has body piercing jewelry through the nipple that cannot be removed.

5. 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).

6. Patient has inflammatory skin disease (i.e., psoriasis, eczema) affecting the breast.

7. Currently taking hormonal replacement therapy

8. Non-ambulatory or unable to comply with exam

9. Weight in excess of exam table limits of 230 LB

10. Prior biopsy clips present

11. Implants present

12. Pregnancy at 6 weeks or later when position on the stomach is not recommended or
difficult (pregnancy test till not be required).

13. Breastfeeding

14. Previous breast radiation or surgery

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

LOUIS 3D Capability to Detect and Differentiate Breast Tumors

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:


Principal Investigator

Wei Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030