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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00574392
Other study ID # 06-136
Secondary ID
Status Completed
Phase N/A
First received December 13, 2007
Last updated December 17, 2015
Start date November 2006
Est. completion date September 2013

Study information

Verified date December 2015
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (3)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Institutes of Health (NIH), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate and quantify image information and image quality provided by multiwavelength and coherence RCM. once while on study No
Secondary To estimate interobserver agreement for specific dermal and epidermal structures observed with multiwavelength and coherence RCM. once during study No
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