MelaFind Evaluations for Patients With Multiple Nevi

MELA Sciences, Inc.19 enrolled

Overview

We have added objectives 4-6 to our updated study: Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient. Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions. Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity. Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics. Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion. Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Clinically Atypical Pigmented Skin Lesion

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria: Inclusion Criteria: * The lesion is pigmented (i.e., melanin, keratin, blood) * The diameter of the pigmented area is not \< 2 mm, and not \> 22 mm * The lesion is accessible to the MelaFind * The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form; Cutaneous lesions that meet any of the following exclusion criteria will not be accepted: 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)

MelaFind Evaluations for Patients With Multiple Nevi

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes