Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Phase 3

Completed

• Conditions: Melanoma
• Interventions: Device: MelaFind(R)

• Registration Number: NCT00434057
• Lead Sponsor: MELA Sciences, Inc.

Brief Summary

The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-12
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-05-26
• Results First Submitted QC: 2009-11-10
• Results First Posted: 2009-11-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1383

Inclusion Criteria

• The lesion is pigmented (i.e., melanin, keratin, blood)
• Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
• The diameter of the pigmented area is between 2 and 22 millimeters
• The lesion is accessible to the MelaFind hand-held imaging device
• The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria

• The patient has a known allergy to isopropyl alcohol
• The lesion has been previously biopsied, excised, or traumatized
• The skin is not intact (e.g., open sores, ulcers, bleeding)
• The lesion is within 1 cm of the eye
• The lesion is on mucosal surfaces (e.g., lips, genitals)
• The lesion is on palmar hands
• The lesion is on plantar feet
• The lesion is on or under nails
• The lesion is located on or in an area of visible scarring
• The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsied Pigmented Skin Lesions	MelaFind(R)	Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	Within 120 days of Data Lock	Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.

Secondary Outcome Measures

Name	Time	Method
Biopsy Ratio	Within 120 days of Data Lock	Number of lesions bioopsied to melanomas detected
Exploratory Analyses	Within 365 days of Data Lock

Trial Locations

Locations (2)

Skin and Cancer Associates; 🇺🇸 Plantation, Florida, United States

Dermatology Associates of Tallahassee; 🇺🇸 Tallahassee, Florida, United States