Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Conditions
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Melanoma

Intervention / Treatment
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* Device: MelaFind(R)


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biopsied Pigmented Skin Lesions<br>Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto | Device: MelaFind(R)<br>* Biopsy ratio comparison<br>* Other names: MelaFind Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma. | Within 120 days of Data Lock | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy Ratio | Number of lesions bioopsied to melanomas detected | Within 120 days of Data Lock | 
| Exploratory Analyses |  | Within 365 days of Data Lock | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind