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A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633516
First Posted: March 12, 2008
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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.

Condition Intervention
Skin Cancer Device: Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • 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


Enrollment: 37
Study Start Date: July 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medical tool
Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
Device: Optical Spectroscopy
Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
Other Name: Optical Spectroscopy imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633516


Locations
United States, California
Beckman Laser Medical clinic, UCI
Irvine, California, United States, 92612
UCIMC
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: David JB Hsiang, MD Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, David Hsiang, M.D., Division of Surgical Oncology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00633516     History of Changes
Other Study ID Numbers: NIH-LAMMP-2088-6099
First Submitted: March 4, 2008
First Posted: March 12, 2008
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
moles
melanoma

Additional relevant MeSH terms:
Skin Neoplasms
Pigmentation Disorders
Neoplasms by Site
Neoplasms
Skin Diseases
Pathologic Processes