NCT00785369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

November 4, 2008

Last Update Submit

October 2, 2012

Conditions

Skin CancerMelanomaLentigo Maligna

Keywords

skin disordersskin cancermelanomalentigo maligna

Outcome Measures

Primary Outcomes (1)

  • To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis.

    Once while on study

Secondary Outcomes (1)

  • To assess interobserver variability associated with interpreting confocal images for detecting cutaneous melanoma and to assess confocal correlations in a qualitative manner.

    Once while on study

Study Arms (1)

1

OTHER

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

Device: Reflectance confocal microscopy

Interventions

Reflectance confocal microscopyDEVICE

Reflectance confocal microscopy (VivaScope 1500)

Also known as: Device
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Loma Linda University

Loma Linda, California, 92354, United States

Location

VA Loma Linda Health Care System

Loma Linda, California, 92357, United States

Location

Skin and Cancer Assoicates

Plantation, Florida, 33324, United States

Location

Memorial Sloan-Kettering Cancer Center

Hauppauge, New York, 11788, United States

Location

Memorial Sloan-Kettering Cancer Center

Manhattan, New York, 10022, United States

Location

University of Rochester Medical Center

Rochester, New York, 14534, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsMelanomaHutchinson's Melanotic FreckleSkin Diseases

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and Melanomas

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

US(6)