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

Tracking Information

First Received Date ^ICMJE

March 4, 2008

Last Updated Date

March 13, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

establish the variance of optical measurements in human pigmented lesions (benign and malignant). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00633516 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Pilot Study to Evaluate Optical Spectroscopy and SIAscopy of Pigmented Skin Lesions

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Skin Cancer

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00633516

Responsible Party

David Hsiang, MD, Lead Researcher, Beckman Laser Institute, UCI

Study ID Numbers ^ICMJE

RR-01192-29, LAMMP WIFI, LAMMP DOS

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David JB Hsiang, MD

Beckman Laser Institute University of California Irvine

Information Provided By

University of California, Irvine

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP