NCT00434057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,383

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 11, 2009

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

February 8, 2007

Results QC Date

May 26, 2009

Last Update Submit

February 10, 2012

Conditions

Melanoma

Keywords

Pigmented Skin LesionsDermatologySkin CancerMelanomaMelaFind

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

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

    Within 120 days of Data Lock

Secondary Outcomes (2)

  • Biopsy Ratio

    Within 120 days of Data Lock

  • Exploratory Analyses

    Within 365 days of Data Lock

Study Arms (1)

Biopsied Pigmented Skin Lesions

OTHER

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

Device: MelaFind(R)

Interventions

MelaFind(R)DEVICE

Biopsy ratio comparison

Also known as: MF100, MelaFind Device System, MelaFind Device
Biopsied Pigmented Skin Lesions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skin and Cancer Associates

Plantation, Florida, 33324, United States

Location

Dermatology Associates of Tallahassee

Tallahassee, Florida, 32317, United States

Location

Related Publications (1)

  • 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. doi: 10.1001/archdermatol.2010.302. Epub 2010 Oct 18.

    PMID: 20956633DERIVED

Related Links

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Joanna Adrian / Director, Clinical Operations and Medical Affairs
Organization
Electro-Optical Sciences, Inc.
adrian@eosciences.com
(914)591-3783

Study Officials

  • Dina Gutkowicz-Krusin, PhD

    Electro-Optical Sciences, Inc.

    STUDY DIRECTOR

  • Joseph V Gulfo, MD, MBA

    Electro-Optical Sciences, Inc.

    STUDY DIRECTOR

  • Harold S Rabinovitz, MD

    Skin and Cancer Associates

    STUDY CHAIR

  • Armand B Cognetta, Jr, MD

    Dermatology Associates of Tallahassee

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 14, 2012

Results First Posted

November 11, 2009

Record last verified: 2012-02

Locations

US(2)