At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call frequency-domain photon migration(FDPM) using Diffuse Optical Spectroscopy (DOS).

DOS methods are based on using intensity-modulated near-infrared light (NIR) to quantitatively measure intrinsic tissue absorption and scattering coefficients in vivo (UCI HS#1995-563). Optical properties can be used to spectroscopically quantify biological components in the tissue namely: deoxy-hemoglobin, oxy-hemoglobin, lipids, and water concentrations, which are related to tissue physiology and functioning. DOS techniques have shown success in characterizing tumor tissue and monitoring neoadjuvant chemotherapy(UCI HS#2002-2306).

Our objective in this study is to monitor the changes in the biochemical composition of the breast during the menstrual cycle of pre-menopausal women using DOS. Volume measurements will also be performed on each subject throughout the menstrual cycle to assess the amount of breast volume change. This study will allow us to accurately correlate DOS parameters to the dominant hormones present in the breast tissue at a given time as well as the physical changes in the breast that results from these hormone fluctuations.

After time of ovulation has been determined during the two months of self-monitoring the DOS measurements are performed using the laser breast scanner, which includes a hand-held probe with optical fibers same procedure of HS#1995-563 and HS#2002-2306. The hand-held probe is applied to the surface of the breast skin with no pressure, but only to ensure skin contact with the probe. Light is launched serially into tissue.

Subject will not feel pain or discomfort. DOS measurements will be taken on only the left breast. Fifteen points on the breast will be marked by using a non allergy surgical pen and markings will be removed after each measurement . Each individual DOS measurement takes about 20 seconds. Measurements will be repeated one time, amounting to a total of 30 measurements that will take approximately 30 minutes. The power of the light source is <20 mW, which is diffuse and comparable to halogen-bulb household flashlights. Following the DOS procedure measurements the breast will place into a 2-liter beaker filled with water. The volume of the breast is determined by measuring the volume of water displaced by the breast.

There are no direct diagnostic benefit can be expected from participation in this study. However, information obtained may lead to a new diagnostic technique to detect breast cancer that may prevent unnecessary surgery and may help improve breast cancer treatment.

Inclusion Criteria:

• Pre-Menopausal female 18 years of age or older with normal breast tissue
• Undergoes regular menstrual cycle cycles that do not vary by more than 5 days

Exclusion Criteria:

• Peri-Menopausal and Post-Menopausal
• Subjects taking oral contraceptives or any birth control medications in the past six months
• Diagnosed with breast cancer or cancer survivor,a history of breast surgery
• Subjects taking light sensitive drugs for photodynamic therapy

• Beckman Laser Institute University of California Irvine
• Volighten Scientific, Ltd.