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

Purpose

The purpose of this study is to evaluate the physiological correlates of two imaging devices (1)Modified Two Layer Diffuse Optical Spectroscopy (MTL DOS ) and (2)SIAscopy 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

Skin Cancer

MedlinePlus related topics:

Cancer Melanoma Moles Skin Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy and SIAscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters

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: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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
	UCIMC
	Orange, California, United States, 92868
	Beckman Laser Medical clinic, UCI
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	David JB Hsiang, MD	Beckman Laser Institute Medical Clinic

More Information

Responsible Party:	Beckman Laser Institute, UCI ( David Hsiang, MD, Lead Researcher )
Study ID Numbers:	P41-RR01192
First Received:	March 4, 2008
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00633516
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

moles

melanoma

Study placed in the following topic categories:

Nevus

Skin Neoplasms

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Skin Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00633516