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OpenTrials
Completed

NCT Number: NCT00633516

A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beckman Laser Medical clinic, UCI, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical Spectroscopy

Device

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

Other names: Optical Spectroscopy imaging

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2008
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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