Primary Investigator: Rosa Cuenca MD
Co-primary investigators: Ron Allison MD, Hu, Sibata and Anastasia Sigounas

This is a research program on noninvasive optical diagnosis of malignant melanoma among pigmented skin lesions.

Current diagnosis of melanoma requires clinical expertise, biopsies and follow-up visits. If the diagnostic method under study in this research project is proven to be at least equal to the present method of detection, it would eliminate patients with benign nevi from being biopsied.

As the medical costs rise rapidly, development of in vivo, accurate, noninvasive and cost-effective optical imaging systems for accurate diagnosis of skin cancer, dysplastic and other skin lesions becomes increasingly important.

Research on the quantitative aspects of in vivo imaging of human skin can lead to a wide range of applications including determination of optical parameter distribution for skin optics research, diagnostic of skin lesions and monitoring skin treatment for clinical research. About 50 patients per year will be enrolled in this study which will be carried out at the Pitt County Memorial Hospital as part of the Brody School of Medicine at East Carolina University.

Patients' skin lesions will be illuminated by a light beam from a monochromatic light source with wavelength between 500 and 1000 nm and imaged using a CCD camera. These images will be analyzed for content of special and spatial patterns due to the morphological characteristic of the pigmented lesion and compared to, if available, conventional biopsy. The imagine equipment was built at the Biomedical Laser Laboratory of ECU for this research project.

Procedure
Imaging sessions start by positioning the participant's skin lesion against an optical glass window through which the illuminating light beam transmits. Selected pigmented skin lesions are marked and set for image acquisition on an outpatient basis during the participant's clinical visit to the Leo Jenkins Cancer Center at East Carolina University.

The imaging process takes five to 20 minutes to complete. A thin film of ultrasound gel may be applied between the participant's skin and the window to reduce the effect of skin surface roughness on imaging. Participants are asked to keep still during the imaging session. After the imaging session, the imaged site on the participant's skin is cleaned.

Risks
The risk involved in the imaging process is minimal because the wavelength of the illumination light is within the visible and near-infrared spectral region from 500 nm to 1000 nm without presence of any ultraviolet or other forms of radiation that are known to cause cancer.

Furthermore, the light beam is produced by a non-laser source and its intensity is much smaller than the intensity threshold for causing skin damage. Thus, no physical or psychological risks or discomforts are expected. Participants are urged to discuss any questions they have about this study with the staff members who will explain it to them.

Potential Benefits
There may or may not be a direct medical benefit to participants. The information learned from this study may benefit other patients with skin lesions. Possible benefits of the research to the subject is that since researchers are scanning the lesions with the CCD camera, they may find the site that was not picked up by the physician using conventional methods of detection. The patients with suspected areas will be sent back to the physician for a biopsy of the suspected site.