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

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ClinicalTrials.gov Identifier: NCT00574392
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : December 18, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Rochester
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.


Condition or disease Intervention/treatment
Basal Cell Carcinoma Melanoma Non-Malignant Skin Disorders Squamous Cell Carcinoma Device: Multiwavelength and coherence confocal reflectance microscopy (Vivascope 1500m multiwavelength)

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
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo
Study Start Date : November 2006
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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.




Primary Outcome Measures :
  1. To evaluate and quantify image information and image quality provided by multiwavelength and coherence RCM. [ Time Frame: once while on study ]

Secondary Outcome Measures :
  1. To estimate interobserver agreement for specific dermal and epidermal structures observed with multiwavelength and coherence RCM. [ Time Frame: once during study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dermatology outpatient clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574392


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
University of Rochester
Investigators
Principal Investigator: Allan Halpern, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00574392     History of Changes
Other Study ID Numbers: 06-136
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
skin disorders

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell