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A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00633516
First received: March 4, 2008
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the physiological correlates of imaging devices,Modified Two Layer Diffuse Optical Spectroscopy (MTL DOS ) in the evaluation of atypical moles and melanoma.

A typical moles and melanoma will have a different optical profile based on physiological parameters compared to benign nevus.

The first measured is to determine the hardware variability. From this optical data, a "correction" curve will be developed and this will be applied to all subsequent optical measurements.


Condition Intervention
Skin Cancer
 Device: optical imaging

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:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • establish the variance of optical measurements in human pigmented lesions (benign and malignant). [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: optical imaging
    skin imaging
Detailed Description:

The researcher using 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.

Specifically,to compare malignant vs. benign lesions.

The skin lesion will be exam and diagnose by the physician. The picture will be obtain by the technician use these two devices before and after the treatment of the lesion.

  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
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
Montana Compton
Investigators
Principal Investigator: David JB Hsiang, MD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00633516     History of Changes
Other Study ID Numbers: D/EB009451-01, LAMMP
Study First Received: March 4, 2008
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
moles
melanoma

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

ClinicalTrials.gov processed this record on May 19, 2013