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

Common Melanocytic Nevi Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01194947
• Other study ID #: SHEBA-10-8015-AS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 2, 2010
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2010
• Source: Sheba Medical Center
• Contact: ALON SCOPE, MD
• Phone: 972-3-5302443
• Email: scopea1[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Common Melanocytic Nevi
• Nevus
• Nevus, Pigmented

Intervention

Device:
• RCM imaging
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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Rmat-gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).		3 YEARS	No
Secondary	Description of rates of retention and change in RCM pattern of nevi during follow-up		3 YEARS	No