Clinical trial NCT00785369: In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis
Official title: In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Melanoma
Lentigo Maligna
Keywords: skin disorders
skin cancer
melanoma
lentigo maligna
Lead sponsor: Lucid
Sponsor class: UNKNOWN
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Loma Linda University
name: University of Rochester
name: VA Loma Linda Health Care System
name: Skin and Cancer Associates in Plantation,Fl.
name: Harvard University
First posted: 2008-11-05
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis.
timeFrame: Once while on study
Secondary outcomes:
measure: To assess interobserver variability associated with interpreting confocal images for detecting cutaneous melanoma and to assess confocal correlations in a qualitative manner.
timeFrame: Once while on study
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Health Care System
state: California
city: Plantation
country: United States
facility: Skin and Cancer Assoicates
state: Florida
city: Hauppauge
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Manhattan
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Memorial Sloan-Kettering Cancer Center, Manhattan
name: Allan C Halpern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center, Hauppauge
name: Ashfaq Marghoob, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda Univeristy Adventist Health Sciences Center
name: Abel Torres, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Lisa Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin and Cancer Associates, Plantation Fl.
name: Harold S Rabinovitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Loma Linda Health Care System
name: Abel Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: