In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis - Full Text View

Sponsors and Collaborators:	Lucid, Inc. Memorial Sloan-Kettering Cancer Center Loma Linda University University of Rochester VA Loma Linda Health Care System Skin and Cancer Associates in Plantation,Fl. Harvard University
Information provided by:	Lucid, Inc.
ClinicalTrials.gov Identifier:	NCT00785369

Purpose

The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an imaging technology called in vivo reflectance confocal microscopy. This technology uses low intensity laser to image below the surface of the skin. The confocal images of the suspicious skin lesion will be examined. The goal of this study is to compare the results of the confocal image examination to the pathologic diagnosis of the skin lesion.

The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The term "in vivo" means in/on a living subject. In this study you will be the living subject and the confocal microscope will be placed on your skin to look at your skin lesion. The confocal microscope uses a weak laser light and a sophisticated lens to image the individual cells that make up the skin. Your lesion will be photographed with high resolution photography.

Condition	Intervention
Skin Cancer Melanoma Lentigo Maligna	Device: Reflectance confocal microscopy

MedlinePlus related topics: Cancer Melanoma Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-Center Study

Further study details as provided by Lucid, Inc.:

Primary Outcome Measures:

To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis. [ Time Frame: Once while on study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess interobserver variability associated with interpreting confocal images for detecting cutaneous melanoma and to assess confocal correlations in a qualitative manner. [ Time Frame: Once while on study ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo	Device: Reflectance confocal microscopy Reflectance confocal microscopy (VivaScope 1500)

Detailed Description:

Patients will be imaged with the VivaScope 1500 reflectance confocal microscope during a single patient visit. The lesion will be photographed with high resolution photography and a high resolution dermoscopic device.

The lesion will then be prepared for RCM imaging. A skin contact device consisting of a metal ring and window will be applied to the skin surrounding the lesion of interest with a disposable medical grade adhesive. A wetting solution will be placed onto the skin. The wetting solutions include a high index oil such as a clear cosmetic oil or mineral oil. A wetting solution such as ultrasound gel will also be placed on the lens of the microscope. Application of these agents diminishes artifacts caused by light scattering at the skin surface. RCM images of the lesion will be captured through the window/contact device using the Vivascope 1500 reflectance confocal microscope provided by Lucid, Inc. Two types of images will be collected, mosaics and stacks. Mosaics are 12x12 confocal images that are optically combined or "stitched" together to create a seamless representation of a 6mm x 6mm total area at specific depths within the skin. Stacks are 0.5mm x 0.5mm confocal images taken at 5 micron intervals from the keratin layer to the superficial dermis. Mosaics and stacks will be acquired for the skin lesion. The total estimated imaging time for a patient in this study is about 10 minutes for each lesion. More than one lesion may be imaged per patient.

After the imaging is complete, the lesion will be biopsied. All lesion images will be saved on a network server for later review and analysis. All imaging will be completed by trained research staff familiar with confocal imaging.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing biopsy for a pigmented lesion suspicious for malignancy.
Patients undergoing biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
Ability to give informed consent.

Exclusion Criteria:

Lesion suspicious for melanoma located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
The lesion (suspicious for melanoma) is located on soles of the feet or palms of the hands.
Inability to give informed consent.
Known hypersensitivity to adhesive rings.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785369

Locations

United States, California
VA Loma Linda Health Care System	Not yet recruiting
Loma Linda, California, United States, 92357
Contact: Abel Torres, MD 909-558-2055 abelt@aol.com
Loma Linda University	Recruiting
Loma Linda, California, United States, 92354
Contact: Abel Torres, MD 909-558-2055 abelt@aol.com
United States, Florida
Skin and Cancer Assoicates	Not yet recruiting
Plantation, Florida, United States, 33324
Contact: Harold S Rabinovitz, MD 954-473-6750 harold@admcorp.com
United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States, 14534
Contact: Lisa Beck, MD 585-275-1039 lisa_beck@urmc.rochester.edu
Memorial Sloan-Kettering Cancer Center	Recruiting
Hauppauge, New York, United States, 11788
Contact: Ashfaq Marghoob, MD 631-863-5106 marghooa@mskcc.org
Memorial Sloan-Kettering Cancer Center	Recruiting
Manhattan, New York, United States, 10022
Contact: Allan Halpern, MD 212-610-0766 halperna@mskcc.org

Sponsors and Collaborators

Lucid, Inc.

Memorial Sloan-Kettering Cancer Center

Loma Linda University

University of Rochester

VA Loma Linda Health Care System

Skin and Cancer Associates in Plantation,Fl.

Harvard University

Investigators

Principal Investigator:	Allan C Halpern, MD	Memorial Sloan-Kettering Cancer Center, Manhattan
Principal Investigator:	Ashfaq Marghoob, MD	Memorial Sloan Kettering Cancer Center, Hauppauge
Principal Investigator:	Abel Torres, MD	Loma Linda Univeristy Adventist Health Sciences Center
Principal Investigator:	Lisa Beck, MD	University of Rochester
Principal Investigator:	Harold S Rabinovitz, MD	Skin and Cancer Associates, Plantation Fl.
Principal Investigator:	Abel Torres, MD	VA Loma Linda Health Care System

More Information

Responsible Party:	Lucid, Inc. ( Jay M. Eastman PhD )
Study ID Numbers:	LI058054, 5R44CA058054-06
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785369
Health Authority:	United States: Institutional Review Board

Keywords provided by Lucid, Inc.:

skin disorders
skin cancer
melanoma
lentigo maligna

Study placed in the following topic categories:

Hyperpigmentation
Hutchinson's Melanotic Freckle
Lentigo
Skin Diseases
Pigmentation Disorders
Skin Neoplasms
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Melanosis
Nevus
Lentigo maligna melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009