Clinical trial NCT00434057: Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Official title: Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind
Lead sponsor: MELA Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 1383
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: Within 120 days of Data Lock
Secondary outcomes:
measure: Biopsy Ratio
timeFrame: Within 120 days of Data Lock
measure: Exploratory Analyses
timeFrame: Within 365 days of Data Lock
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Skin and Cancer Associates
state: Florida
city: Tallahassee
country: United States
facility: Dermatology Associates of Tallahassee
state: Florida
Study officials:
affiliation: Electro-Optical Sciences, Inc.
name: Dina Gutkowicz-Krusin, PhD
role: STUDY_DIRECTOR
affiliation: Electro-Optical Sciences, Inc.
name: Joseph V Gulfo, MD, MBA
role: STUDY_DIRECTOR
affiliation: Skin and Cancer Associates
name: Harold S Rabinovitz, MD
role: STUDY_CHAIR
affiliation: Dermatology Associates of Tallahassee
name: Armand B Cognetta, Jr, MD
role: STUDY_CHAIR
References:
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.