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In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

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ClinicalTrials.gov Identifier: NCT00785369
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : October 3, 2012
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 (Responsible Party):
Lucid, Inc.

Brief Summary:

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 or disease Intervention/treatment
Skin Cancer Melanoma Lentigo Maligna Device: Reflectance confocal microscopy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study
Study Start Date : August 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo
Device: Reflectance confocal microscopy
Reflectance confocal microscopy (VivaScope 1500)
Other Name: Device

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785369

United States, California
Loma Linda University
Loma Linda, California, United States, 92354
VA Loma Linda Health Care System
Loma Linda, California, United States, 92357
United States, Florida
Skin and Cancer Assoicates
Plantation, Florida, United States, 33324
United States, New York
Memorial Sloan-Kettering Cancer Center
Hauppauge, New York, United States, 11788
Memorial Sloan-Kettering Cancer Center
Manhattan, New York, United States, 10022
University of Rochester Medical Center
Rochester, New York, United States, 14534
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
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.
ClinicalTrials.gov Identifier: NCT00785369     History of Changes
Other Study ID Numbers: LI058054
5R44CA058054-06 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by Lucid, Inc.:
skin disorders
skin cancer
lentigo maligna

Additional relevant MeSH terms:
Skin Neoplasms
Hutchinson's Melanotic Freckle
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Pigmentation Disorders