Trial Information

Spectral Diagnosis of Cutaneous Malignancy

The spectral-diagnosis probe being used in this study uses dim pulses of light to identify
features of tissue that may be related to the status of skin cancer. The probe is shaped
like a catheter, and it has a camera on the end, which takes pictures of the skin.

If you agree to take part in this study, you will be asked questions about your age, race,
smoking status, and the status of any diseases you may have (such as diabetes, connective
tissue disease, and infectious disease). It should take about 5 minutes to answer these
questions.

The study doctor will then decide which of your lesions are suitable for imaging by the
probe. If necessary, any hair on or around the lesion(s) will be shaved or trimmed. The
area(s) of skin being imaged will be cleaned with rubbing alcohol.

As part of your exam, the study doctor will use the probe to measure the selected areas of
tissue. To perform the spectral-diagnosis measurement, the probe will be gently placed on
the surface of your skin. Each selected area of your skin will take about a few seconds to
image. The probe will shine different types of light onto the skin, and it will collect the
light that reflects from the skin surface. The light signals will be stored so that
researchers can look at them. Preparing the lesion, imaging it, and collecting the light
signals should take about 10-15 minutes per lesion.

After all of the imaging is over, you will have biopsies performed on the lesions that your
study doctor has decided are in need of such treatment as part of your standard care.

After this clinic visit, your participation in the study will be over.

This is an investigational study. The imaging probe is not commercially available or FDA
approved. At this time, it is being used in research only. Up to 150 patients will take
part in this study. All will be enrolled at M. D. Anderson.