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

February 8, 2007
February 10, 2012
January 2007
July 2008   (final data collection date for primary outcome measure)
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.
  • Sensitivity
  • Specificity
Complete list of historical versions of study NCT00434057 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Diagnostic Accuracy
  • ROC Curve Analysis
  • Exploratory Analyses
Not Provided
Not Provided
 
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Evaluation of Pigmented Skin Lesions With MelaFind(R) System

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Melanoma
Device: MelaFind(R)
Biopsy ratio comparison
Other Names:
  • MF100
  • MelaFind Device System
  • MelaFind Device
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)
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.
 
Completed
1383
July 2008
July 2008   (final data collection date for primary outcome measure)

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)
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00434057
20061
No
MELA Sciences, Inc.
MELA Sciences, Inc.
Not Provided
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
MELA Sciences, Inc.
February 2012

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