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Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MelaFind(R)
Sponsored by
MELA Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Skin and Cancer Associates
  • Dermatology Associates of Tallahassee

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biopsied Pigmented Skin Lesions

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity and Specificity
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
Number of lesions bioopsied to melanomas detected
Exploratory Analyses

Full Information

First Posted
February 8, 2007
Last Updated
February 10, 2012
Sponsor
MELA Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00434057
Brief Title
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Official Title
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MELA Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biopsied Pigmented Skin Lesions
Arm Type
Other
Arm Description
Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Intervention Type
Device
Intervention Name(s)
MelaFind(R)
Other Intervention Name(s)
MF100, MelaFind Device System, MelaFind Device
Intervention Description
Biopsy ratio comparison
Primary Outcome Measure Information:
Title
Sensitivity and Specificity
Description
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
Time Frame
Within 120 days of Data Lock
Secondary Outcome Measure Information:
Title
Biopsy Ratio
Description
Number of lesions bioopsied to melanomas detected
Time Frame
Within 120 days of Data Lock
Title
Exploratory Analyses
Time Frame
Within 365 days of Data Lock

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Gutkowicz-Krusin, PhD
Organizational Affiliation
Electro-Optical Sciences, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph V Gulfo, MD, MBA
Organizational Affiliation
Electro-Optical Sciences, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Harold S Rabinovitz, MD
Organizational Affiliation
Skin and Cancer Associates
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Armand B Cognetta, Jr, MD
Organizational Affiliation
Dermatology Associates of Tallahassee
Official's Role
Study Chair
Facility Information:
Facility Name
Skin and Cancer Associates
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Dermatology Associates of Tallahassee
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32317
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20956633
Citation
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.
Results Reference
derived
Links:
URL
http://www.eosciences.com
Description
Sponsor Web Site

Learn more about this trial

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

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