Skin and Connective Tissue Diseases

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Rare Diseases

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Melanoma

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Hutchinson's Melanotic Freckle

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Neuroectodermal Tumors, Primitive

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Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Melanosis

Hyperpigmentation

Pigmentation Disorders

Neuroendocrine Tumor

Neuroepithelioma

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

Reflectance confocal microscopy (VivaScope 1500)

Reflectance confocal microscopy

Allan C Halpern, MD

Ashfaq Marghoob, MD

Abel Torres, MD

Lisa Beck, MD

Harold S Rabinovitz, MD

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.

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.

In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study

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

Lucid, Inc.

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms, Basal Cell

Multiwavelength and coherence confocal reflectance microscopy of pigmented and nonpigmented lesions on skin in vivo

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.

Multiwavelength and coherence confocal reflectance microscopy (Vivascope 1500m multiwavelength)

Allan Halpern, MD

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.

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.

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

National Institutes of Health (NIH)

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Breast Neoplasms

Communicable Diseases

Prostatic Neoplasms

Sarcoma

Lung Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

James L Gulley, M.D.

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.

Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.

...

Background:

Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.

Objectives:

Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.

Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.

Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Eligibility:

Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.

Design:

This protocol is not a research study of an investigational drug or device.

Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.

In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Tissues and biological fluids that are obtained during the screening process will be stored.

Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.

Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research

Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values

Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions

Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.

Evaluate patient eligibility for participation in NCI/CCR research protocols

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis	NCT00785369	Skin Cancer Melanoma Lentigo Maligna	Reflectance con...	18 Years -	Lucid
In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis	NCT00785369	Skin Cancer Melanoma Lentigo Maligna	Reflectance con...	18 Years -	Lucid
Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo	NCT00574392	Basal Cell Carc... Melanoma Non-Malignant S... Squamous Cell C...	Multiwavelength...	18 Years -	Memorial Sloan Kettering Cancer Center
Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo	NCT00574392	Basal Cell Carc... Melanoma Non-Malignant S... Squamous Cell C...	Multiwavelength...	18 Years -	Memorial Sloan Kettering Cancer Center
Eligibility Screening for the NIH Intramural Research Program Clinical Protocols	NCT00026754	Breast Cancer Prostate Cancer Lung Cancer Sarcoma Melanoma		1 Month -	National Institutes of Health Clinical Center (CC)

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