- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785369
In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis
In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Loma Linda University
-
Loma Linda, California, United States, 92357
- VA Loma Linda Health Care System
-
-
Florida
-
Plantation, Florida, United States, 33324
- Skin and Cancer Assoicates
-
-
New York
-
Hauppauge, New York, United States, 11788
- Memorial Sloan-Kettering Cancer Center
-
Manhattan, New York, United States, 10022
- Memorial Sloan-Kettering Cancer Center
-
Rochester, New York, United States, 14534
- University of Rochester Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Device: In vivo reflectance confocal microscopy of pigmented lesions in vivo
|
Reflectance confocal microscopy (VivaScope 1500)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Once while on study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Once while on study
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Hyperpigmentation
- Pigmentation Disorders
- Melanosis
- Melanoma
- Skin Neoplasms
- Lentigo
- Hutchinson's Melanotic Freckle
Other Study ID Numbers
- LI058054
- 5R44CA058054-06 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Viewpoint Molecular TargetingRecruitingMetastatic Melanoma | Melanoma (Skin) | Mucosal Melanoma | Melanoma Stage IV | Melanoma Stage III | Melanoma, UvealUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on Reflectance confocal microscopy
-
Memorial Sloan Kettering Cancer CenterRecruitingHead and Neck Cancer | Squamous Cell Carcinoma (SCC) of the Oral CavityUnited States
-
Julie DawsonCompletedBasal Cell CarcinomaUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterCompleted
-
Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH); University of RochesterCompletedMelanoma | Basal Cell Carcinoma | Squamous Cell Carcinoma | Non-Malignant Skin DisordersUnited States
-
Memorial Sloan Kettering Cancer CenterPhysical Sciences Inc.Recruiting
-
Centre Hospitalier Universitaire de Saint EtienneCompletedMelanoma | Nevus | Lentigo | Basal Cell Carcinoma | Seborrheic Keratosis | Lentigo MalignaFrance
-
Technische Universität DresdenCompletedNon-melanoma Skin CancerGermany
-
Memorial Sloan Kettering Cancer CenterRecruitingBasal Cell CarcinomaUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...The Netherlands Cancer InstituteCompletedCarcinoma, Basal CellNetherlands
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed