Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Melanoma Clinical Trial

Official title:

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434057
• Other study ID #: 20061
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: February 10, 2012
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2012
• Source: MELA Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1383
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Pigmentation Disorders

Intervention

Device:
• MelaFind(R)
Biopsy ratio comparison

Locations

Country	Name	City	State
United States	Skin and Cancer Associates	Plantation	Florida
United States	Dermatology Associates of Tallahassee	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MELA Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Biopsy Ratio	Number of lesions bioopsied to melanomas detected	Within 120 days of Data Lock	No
Secondary	Exploratory Analyses		Within 365 days of Data Lock	No