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A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

NCT ID: NCT00633516

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Skin Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Medical tool

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

Optical Spectroscopy

Intervention Type DEVICE

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

Interventions

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Optical Spectroscopy

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

Intervention Type DEVICE

Other Intervention Names

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Optical Spectroscopy imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

David Hsiang, M.D., Division of Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David JB Hsiang, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Bruce Tromberg, PhD

Role: STUDY_DIRECTOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Medical clinic, UCI

Irvine, California, United States

Site Status

UCIMC

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20086099

Identifier Type: -

Identifier Source: org_study_id

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