Evaluation of Pigmented Skin Lesions With MelaFind(R) System - Full Text View

Sponsor:	Electro-Optical Sciences
Information provided by:	Electro-Optical Sciences
ClinicalTrials.gov Identifier:	NCT00434057

Purpose

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.

Condition	Intervention	Phase
Melanoma	Device: MelaFind(R)	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by Electro-Optical Sciences:

Primary Outcome Measures:

Sensitivity and Specificity [ Time Frame: Within 120 days of Data Lock ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biopsy Ratio [ Time Frame: Within 120 days of Data Lock ] [ Designated as safety issue: No ]
Exploratory Analyses [ Time Frame: Within 365 days of Data Lock ] [ Designated as safety issue: No ]

Enrollment:	1383
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Biopsied Pigmented Skin Lesions Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto	Device: MelaFind(R) Biopsy ratio comparison

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434057

Locations

United States, Florida
Skin and Cancer Associates
Plantation, Florida, United States, 33324
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States, 32317

Sponsors and Collaborators

Electro-Optical Sciences

Investigators

Study Director:	Dina Gutkowicz-Krusin, PhD	Electro-Optical Sciences, Inc.
Study Director:	Joseph V Gulfo, MD, MBA	Electro-Optical Sciences, Inc.
Study Chair:	Harold S Rabinovitz, MD	Skin and Cancer Associates
Study Chair:	Armand B Cognetta, Jr, MD	Dermatology Associates of Tallahassee

More Information

Additional Information:

Sponsor Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Electro-Optical sciences ( Joanna Adrian )
Study ID Numbers:	20061
Study First Received:	February 8, 2007
Results First Received:	May 26, 2009
Last Updated:	November 10, 2009
ClinicalTrials.gov Identifier:	NCT00434057 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Electro-Optical Sciences:

Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Nevi and Melanomas

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Melanoma
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on November 27, 2009