Trial Information

Monitoring Menstrual Cycle Functional Variation in DOS

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.