Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care - LOUIS-3D Breast Study

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.

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