Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- MELA Sciences, Inc.
- Enrollment
- 1,383
- Locations
- 4
- Primary Endpoint
- Sensitivity and Specificity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Sensitivity and Specificity
Time Frame: 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 Outcomes
- Biopsy Ratio(Within 120 days of Data Lock)
- Exploratory Analyses(Within 365 days of Data Lock)