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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 |
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Information provided by: | Lucid, Inc. |
ClinicalTrials.gov Identifier: | NCT00785369 |
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 |
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Skin Cancer Melanoma Lentigo Maligna |
Device: Reflectance confocal microscopy |
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 |
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 |
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1
Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo
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Device: Reflectance confocal microscopy
Reflectance confocal microscopy (VivaScope 1500)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
skin disorders skin cancer melanoma lentigo maligna |
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 |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |