Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Mela Sciences

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Device: MelaFind(R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434057

20061

Details and patient eligibility

About

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.

Enrollment: 1,383 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,383 participants in 1 patient group

Biopsied Pigmented Skin Lesions

Other group

Description:

Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Treatment:

Device: MelaFind(R)