Evaluation of Pigmented Skin Lesions With MelaFind(R) System

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MELA Sciences, Inc.

ClinicalTrials.gov Identifier:

NCT00434057

First received: February 8, 2007

Last updated: February 10, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2007

Last Updated Date

February 10, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.

Original Primary Outcome Measures ^ICMJE

Sensitivity
Specificity

Change History

Complete list of historical versions of study NCT00434057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Biopsy Ratio [ Time Frame: Within 120 days of Data Lock ] [ Designated as safety issue: No ]
Number of lesions bioopsied to melanomas detected
Exploratory Analyses [ Time Frame: Within 365 days of Data Lock ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Diagnostic Accuracy
ROC Curve Analysis
Exploratory Analyses

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Official Title ^ICMJE

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

Device: MelaFind(R)

Biopsy ratio comparison

Other Names:

MF100
MelaFind Device System
MelaFind Device

Study Arm (s)

Biopsied Pigmented Skin Lesions

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

Intervention: Device: MelaFind(R)

Publications *

Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M, Grichnik JM, Mihm M, Prieto VG, Googe P, King R, Toledano A, Kabelev N, Wojton M, Gutkowicz-Krusin D. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94. Epub 2010 Oct 18.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1383

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00434057

Other Study ID Numbers ^ICMJE

20061

Has Data Monitoring Committee

Responsible Party

MELA Sciences, Inc.

Study Sponsor ^ICMJE

MELA Sciences, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

MELA Sciences, Inc.

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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