MelaFind Evaluations for Patients With Multiple Nevi

Completed

• Conditions: Clinically Atypical Pigmented Skin Lesion

• Registration Number: NCT01700101
• Lead Sponsor: MELA Sciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Study Start: 2012-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions	1 month