In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis
Completed · Not applicable
Conditions studied: Skin Cancer, Melanoma, Lentigo Maligna
In brief
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.
Key facts
- Study ID
- NCT00785369
- Run by
- Lucid, Inc.
- People needed
- 441
- Starts
- 2008-08-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2012-10-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Loma Linda University — Loma Linda, California, United States
- VA Loma Linda Health Care System — Loma Linda, California, United States
- Skin and Cancer Assoicates — Plantation, Florida, United States
- Memorial Sloan-Kettering Cancer Center — Hauppauge, New York, United States
- Memorial Sloan-Kettering Cancer Center — Manhattan, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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