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A novel instrument for evaluating pigmented lesions is useful, a study finds.
The device combines state-of-the art technology for visualizing a lesion's pigment patterns and invasiveness up to 2.5 mm below the skin's surface with sophisticated software that processes the acquired information and generates an immediate result for informing the decision to biopsy.
When placed on a suspicious lesion, the device acquires 10 digital images with illumination in wavelengths ranging from visible to near infrared. It automatically analyzes the images using advanced algorithms, which were created, trained and validated on a biopsy database comprised of more than 9,000 pigmented skin lesions, including more than 600 melanomas.
Investigators examined the MelaFind's diagnostic accuracy in a study involving seven sites across the United States that enrolled 1,831 pigmented skin lesions of 1,383 patients.
Eligible lesions measured between 2 mm and 22 mm in diameter and had already been determined by the examining dermatologist as requiring biopsy.
The outcomes analyses showed that the instrument met its primary outcome endpoints for both sensitivity, which was based on comparison with biopsy diagnosis by a central dermatopathology reading center, and specificity, comparing its results with expert clinician assessments. About half of the melanomas evaluated in the study were melanoma in situ.
"Deciding whether or not to biopsy a pigmented lesion is a scenario dermatologists face multiple times each day in clinical practice.
"Any tool that can assist in this process has important value for improving early detection of melanoma, when the malignancy is most curable, and helping us to reduce the number of unnecessary biopsies, which are costly, uncomfortable, and can lead to scarring," says Gary D. Monheit, M.D., lead investigator in the pivotal study and associate clinical professor of dermatology, University of Alabama, Birmingham.
Darrell S. Rigel, M.D., who is a member of the scientific advisory committee of Electro-Optical Sciences, says he is very excited about the results of the study.
"Considering that an estimated 650,000 new patients in the U.S. annually visit a dermatologist because of concern about a mole, and that anywhere between 4 and 10 million patients are at high risk for developing melanoma, it's clear that clinicians can benefit from better technology that will make us more effective in our diagnoses," says Dr. Rigel, clinical professor of dermatology, New York University School of Medicine, New York.
"While early melanomas can resemble benign lesions clinically, they may have many differentiating subsurface irregular characteristics. This device represents the first technology that offers a view beneath the skin surface, and, even more importantly, that provides a binary result for us to decide whether or not to biopsy.
"To my knowledge, there's no other instrument available or in development that matches its potential as a detection tool for melanoma," he says.
Dr. Rigel adds that, to his knowledge, the pivotal trial is also the largest prospective study of melanoma detection ever conducted.
"This study provides a rich database for additional analyses that I believe will help advance our understanding of melanoma in regards to certain risk factors and current trends," he says.