In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

This study has been completed.
Sponsor:
Collaborators:
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.
ClinicalTrials.gov Identifier:
NCT00785369
First received: November 4, 2008
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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
Skin Cancer
Melanoma
Lentigo Maligna
Device: Reflectance confocal microscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study

Resource links provided by NLM:


Further study details as provided by Lucid, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 441
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo
Device: Reflectance confocal microscopy
Reflectance confocal microscopy (VivaScope 1500)
Other Name: Device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785369

Locations
United States, California
VA Loma Linda Health Care System
Loma Linda, California, United States, 92357
Loma Linda University
Loma Linda, California, United States, 92354
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
Investigators
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
  More Information

No publications provided

Responsible Party: Lucid, Inc.
ClinicalTrials.gov Identifier: NCT00785369     History of Changes
Other Study ID Numbers: LI058054, 5R44CA058054-06
Study First Received: November 4, 2008
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014