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
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Resource links provided by NLM:


Further study details as provided by MELA Sciences, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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
Other Names:
  • MF100
  • MelaFind Device System
  • MelaFind Device

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
MELA Sciences, Inc.
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:
No publications provided by MELA Sciences, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00434057     History of Changes
Other Study ID Numbers: 20061
Study First Received: February 8, 2007
Results First Received: May 26, 2009
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MELA Sciences, Inc.:
Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind

Additional relevant MeSH terms:
Melanoma
Pigmentation Disorders
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014