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Evaluation of Pigmented Skin Lesions With MelaFind(R) System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434057
First Posted: February 12, 2007
Last Update Posted: February 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MELA Sciences, Inc.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    Number of lesions bioopsied to melanomas detected

  • Exploratory Analyses [ Time Frame: Within 365 days of Data Lock ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 8, 2007
First Posted: February 12, 2007
Results First Submitted: May 26, 2009
Results First Posted: November 11, 2009
Last Update Posted: February 14, 2012
Last Verified: February 2012

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
Pathologic Processes