A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00633516
First received: March 4, 2008
Last updated: June 12, 2015
Last verified: June 2015
  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 University of California, Irvine:

Primary Outcome Measures:
  • Measure atypical moles and melanoma [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 4, 2008
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
moles
melanoma

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 01, 2015