In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

NCT ID: NCT00785369

Last Updated: 2012-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Skin Cancer; Melanoma; Lentigo Maligna

Keywords

skin disorders; skin cancer; melanoma; lentigo maligna

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo

Group Type: OTHER

Reflectance confocal microscopy

Intervention Type: DEVICE

Reflectance confocal microscopy (VivaScope 1500)

Interventions

Reflectance confocal microscopy

Reflectance confocal microscopy (VivaScope 1500)

Intervention Type: DEVICE

Other Intervention Names

Device

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

VA Loma Linda Health Care System

FED

Sponsor Role: collaborator

Skin and Cancer Associates in Plantation,Fl.

UNKNOWN

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Lucid, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan C Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan-Kettering Cancer Center, Manhattan

Ashfaq Marghoob, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center, Hauppauge

Abel Torres, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Univeristy Adventist Health Sciences Center

Lisa Beck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Harold S Rabinovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Skin and Cancer Associates, Plantation Fl.

Abel Torres, MD

Role: PRINCIPAL_INVESTIGATOR

VA Loma Linda Health Care System

Locations

University of Rochester Medical Center

Rochester, New York, United States

Loma Linda University

Loma Linda, California, United States

VA Loma Linda Health Care System

Loma Linda, California, United States

Skin and Cancer Assoicates

Plantation, Florida, United States

Memorial Sloan-Kettering Cancer Center

Hauppauge, New York, United States

Memorial Sloan-Kettering Cancer Center

Manhattan, New York, United States

Countries

United States

Other Identifiers

5R44CA058054-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LI058054

Identifier Type: -

Identifier Source: org_study_id