A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633516
• Other study ID #: 20086099
• Status: Completed
• Start date: July 2008
• Est. completion date: November 2013

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pigmentation Disorders
• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Optical Spectroscopy
Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy

Locations

Country	Name	City	State
United States	Beckman Laser Medical clinic, UCI	Irvine	California
United States	UCIMC	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure atypical moles and melanoma	Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology	4 weeks