A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions - Full Text View

Sponsor:	Montana Compton
Information provided by (Responsible Party):	Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00633516

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:

MedlinePlus related topics: Birthmarks Cancer Melanoma Moles Skin Cancer Skin Pigmentation Disorders

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)

Groups/Cohorts	Assigned Interventions
skin inaging Skin lesions	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:	October 28, 2011
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 February 12, 2012