Skip to main content
OpenTrials
Completed

NCT Number: NCT00434057

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Skin and Cancer Associates, Plantation, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MelaFind(R)

Device

Biopsy ratio comparison

Other names: MF100, MelaFind Device System, MelaFind Device

Primary outcomes

  1. 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 outcomes

  1. Biopsy Ratio

    Time frame: Within 120 days of Data Lock

    Number of lesions bioopsied to melanomas detected

  2. Exploratory Analyses

    Time frame: Within 365 days of Data Lock

Sponsors and collaborators

Lead sponsor

MELA Sciences, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 12, 2007
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.