In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

NCT00785369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2012-10-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Reflectance confocal microscopy

Reflectance confocal microscopy (VivaScope 1500)

Sponsors & Collaborators

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER
  • Loma Linda University

    collaborator OTHER
  • University of Rochester

    collaborator OTHER
  • VA Loma Linda Health Care System

    collaborator FED
  • Skin and Cancer Associates in Plantation,Fl.

    collaborator UNKNOWN
  • Harvard University

    collaborator OTHER
  • Lucid, Inc.

    lead INDUSTRY

Principal Investigators

  • Allan C Halpern, MD · Memorial Sloan-Kettering Cancer Center, Manhattan

  • Ashfaq Marghoob, MD · Memorial Sloan Kettering Cancer Center, Hauppauge

  • Abel Torres, MD · Loma Linda Univeristy Adventist Health Sciences Center

  • Lisa Beck, MD · University of Rochester

  • Harold S Rabinovitz, MD · Skin and Cancer Associates, Plantation Fl.

  • Abel Torres, MD · VA Loma Linda Health Care System

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00785369 on ClinicalTrials.gov