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.

Inclusion Criteria:

1. Male or Female and over 18 years of age.

2. Patients undergoing an examination of their skin

3. Patients with a lesion(s) in one of the five categories: basal cell carcinoma,
squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions

4. Patients whose lesion also warrants a biopsy.

5. Signed informed consent document.

Exclusion Criteria:

1. Patients with absence of skin lesion(s) in one of the five categories.

2. Patients whose identified lesion did not need a biopsy.

3. Patients who did not sign the informed consent and agree to participate.