Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy

N/AUnknownNCT01194947

Sheba Medical Center90 enrolled

Overview

Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Common Melanocytic Nevi

Interventions

RCM imagingDEVICE

RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination * Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination. Exclusion Criteria: * Patients who are unwilling or medically unable to lie down for 30 minutes. * Pregnant women

Locations (1)

Sheba Medical Center

Rmat-gan, Israel

Outcomes

Primary Outcomes

Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).

Time frame: 3 YEARS

Secondary Outcomes

Description of rates of retention and change in RCM pattern of nevi during follow-up

Time frame: 3 YEARS

Central Contacts

ALON SCOPE, MD

CONTACT

972-3-5302443 scopea1@gmail.com

Data from ClinicalTrials.gov

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