Trial Information

Measurements of Breast Tissue Optical Properties

Non-invasive measurements of breast tissue optical properties will be performed on the skin
surface using a specially designed FDPM measurement probe which is similar in shape to an
ultrasound probe. The FDPM probe is embedded with optic fibers set at a fixed separation.
The FDPM probe will be placed on different areas of the breast including areas suspected to
have disease and areas appearing to be normal. The diseased location will be identified by
clinical palpation. Some mild tissue compression will be performed within comfort tolerance
of the patient during the application of the FDPM probe.

When the probe is in position, the laser will be activated and a measurement will be taken.
Each measurement will require about 30-60 seconds to record the data and calculate optical
properties. The probe will then be turned off and moved to a new position for further
measurements. The process will be repeated until an adequate number of measurements are
performed (about 10-20). The whole process should take about 30 to 90 minutes.

Anticipate Risk and Benefit;

The optical scan is not expected to cause any pain, burning, or discomfort during or after
the exam. There may be risks, however, that are currently unforeseeable. During all
measurements, the laser will be turned on only when needed. Although not required for
safety, subjects may wear protective eye goggles if requested.

There is no therapeutic benefit to the subject, especially none that might influence the
indication for the diagnostic procedure as indicated. However, information obtained may
lead to a new form of non-invasive imaging for the early detection of breast cancer.