A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

Completed

• Conditions: Skin Cancer
• Interventions: Device: Optical Spectroscopy

• Registration Number: NCT00633516
• Lead Sponsor: University of California, Irvine

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 Timeline

• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-12
• Study Start: 2008-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical tool	Optical Spectroscopy	Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy

Primary Outcome Measures

Name	Time	Method
Measure atypical moles and melanoma	4 weeks	Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology

Trial Locations

Locations (2)

UCIMC; 🇺🇸 Orange, California, United States

Beckman Laser Medical clinic, UCI; 🇺🇸 Irvine, California, United States