A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Measure atypical moles and melanoma
Overview
Brief Summary
The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.
Detailed Description
The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.
The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older.
- •Have atypical mole/s and melanoma
Exclusion Criteria
- •Age less than 18 years old.
- •have NO atypical mole/s and melanoma
Outcomes
Primary Outcomes
Measure atypical moles and melanoma
Time Frame: 4 weeks
Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology
Secondary Outcomes
No secondary outcomes reported
Investigators
Beckman Laser Institute and Medical Center
David Hsiang, M.D., Division of Surgical Oncology
University of California, Irvine