Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo

December 17, 2015 updated by: Memorial Sloan Kettering Cancer Center

The purpose of this study is to image skin and skin lesions with a new imaging technology called "multiwavelength and coherence confocal reflectance microscopy". This technology uses low intensity laser to image below the surface of the skin. This technology may provide a new way of looking at skin and skin lesions. The goal of this study is to evaluate the images of your skin taken by this microscope.

The techniques being evaluated in this study use multi wavelength and coherence confocal reflectance microscopy invivo. The term "in vivo" means in/on a living subject. In this study you will be the living subject and the multi wave length and coherence confocal microscope will be placed on your skin to look at your skin lesions and your normal skin. 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. An area near your skin lesion that is clinically normal will also be imaged in the same manner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be imaged with the Vivascope 1500m multiwavelength coherence microscope during a single patient visit. The lesion will be photographed with high resolution photography and surface epiluminescence microscopy. The clinically uninvolved site will be imaged in the same manner.

The lesion will then be prepped for RCM imaging. A skin contact device consisting of a metal ring and template will be applied to the skin surrounding the lesion of interest with a disposable medicalgrade adhesive plastic disc. A wetting solution will be placed into the metal ring. The wetting solutions include water, mineral oil and other over the counter products (e.g. hairstyling gel and moisturizing agents). Application of these agents diminishes artifacts caused by light scattering at the skin surface. RCM images of the lesion will be captured through the contact device using the Vivascope 1500m surface confocal microscope provided by Lucid Technologies, Inc. Two types of images will be collected, VivaBlocks and VivaStacks. VivaBlocks are a 4x4 mosaic of confocal images that measure 2mm x 2mm in total area. These VivaBlock images are optically combined or "stitched" together by the VivaScope 1500m to create a seamless representation of 4 mm 2 area at a specific depth within the skin. VivaStacks are eight 0.5mm x 0.5mm confocal images taken at 3 micron intervals from the keratin layer to the superficial dermis. VivaStacks and VivaBlocks will be acquired for both the skin lesion and for the clinically uninvolved area of the skin. The total estimated imaging time for a patient in this study is about 30 minutes for the lesion and the clinically uninvolved site.

The confocal imaging session and the dermatologic visit for the punch biopsy do not have to occur during the same patient visit. 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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

dermatology outpatient clinic

Description

Inclusion Criteria:

  • Patients with a pigmented or nonpigmented skin lesion undergoing biopsy.
  • Lesion located on an anatomical site that is readily accessible to the VivaScope 1500m (for example, chest, back, legs, arms, cheek, forehead).
  • Ability to sign informed consent, which indicates the investigational nature of this study.
  • Age ≥ 18.

Exclusion Criteria:

  • Biopsy located on an anatomic site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
  • Inability to give informed consent.
  • Known hypersensitivity to adhesive rings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Multiwavelength and coherence confocal reflectance microscopy of pigmented and nonpigmented lesions on skin in vivo
Device: Multiwavelength and coherence confocal reflectance microscopy (Vivascope 1500m multiwavelength)
Patients will be imaged with the Vivascope 1500m multiwavelength coherence microscope during a single patient visit. The lesion will be photographed with high resolution photography and surface epiluminescence microscopy. The clinically uninvolved site will be imaged in the same manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate and quantify image information and image quality provided by multiwavelength and coherence RCM.
Time Frame: once while on study
once while on study

Secondary Outcome Measures

Outcome Measure
Time Frame
To estimate interobserver agreement for specific dermal and epidermal structures observed with multiwavelength and coherence RCM.
Time Frame: once during study
once during study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)
University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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