Accurate Identification of Melanoma

NEW TOOL FOR FINDING MELANOMA

Melanoma is the most feared of all skin cancers, and with good reason — it’s so deadly that Americans die from it at the rate of one per hour! Adding to the frustration is the fact that melanoma is a cancer that can almost always be seen with the naked eye and that virtually all patients can survive it when it is detected and removed before it metastasizes. It’s excellent news, therefore, that a new medical device called MelaFind can help dermatologists accurately identify the vast majority of melanomas, assessing not only what’s visible on the skin but also what’s beneath the surface — and it just got approved by the FDA in November.

AMAZINGLY ACCURATE

At present, dermatologists must rely on their own experience with detecting melanoma to decide whether or not to biopsy a suspicious mole or growth. Generally, they are inclined to order a biopsy when they see one or more of these characteristics…

• Asymmetry
• Irregularly shaped borders
• Variation in color
• A diameter greater than 6 mm (about the size of a pencil eraser)
• Rapid change
• Change in surface, such as becoming scaly
• Itchiness, pain or bleeding.

But a growth that contains some or many of those characteristics isn’t always melanoma, leading to an unnecessary biopsy, which can cause pain, anxiety, extra costs and occasional complications such as infections and scarring.

MelaFind is a first-of-its kind, noninvasive, objective tool that can help doctors analyze a suspicious lesion to determine if it’s likely melanoma and if it’s worth doing a biopsy. In other words, it’s like a second opinion — but it leaves the actual diagnosis up to the physician. MelaFind is a computer system that looks something like a hand-held blow-dryer that doctors place over the mole in question. Using 10 different light wavelengths (including near infrared bands), it creates a multicolored digital image of the lesion, and then using an algorithm that was developed from a databank of 10,000 images, it examines the shape and depth of the mole to gauge the likelihood of cancer. Here’s the really interesting part — the light penetrates the skin to see what is going on up to 2.5 mm under the surface to determine if the dangerous growth is deep.

The advantages: MELA Sciences, the manufacturer of MelaFind, conducted numerous studies on the device, including a multicenter study that was the largest ever concerning melanoma detection. The study ran from January 2007 to July 2008 and included a total of 1,383 patients with 1,831 lesions for evaluation. The study compared MelaFind’s detection rates to dermatologists’ detection rates when examining the same lesions. It showed that MelaFind outperforms dermatologists when it comes to identification. MelaFind correctly identified 98.4% of melanomas, whereas dermatologists, on average, identified only 78% of melanomas. When it came to identifying noncancerous lesions, MelaFind was also better — but not by much. MelaFind correctly identified only 10% of noncancerous lesions, while dermatologists identified, on average, less than 4% of them. The hope is that this device will lead to earlier diagnoses of actual melanomas and fewer unnecessary biopsies of noncancerous lesions.

AN EXPERT’S OPINION

I contacted skin cancer specialist Ellen Marmur, MD, vice chair of dermatological and cosmetic surgery at Mount Sinai Medical Center in New York City, to see what she thinks about MelaFind. She is excited about the device’s potential but mentioned some limitations. About 8% of growths scanned into the MelaFind device during the company’s study came back with the message “unevaluable.” So MelaFind is unable to examine all lesions — for example, if a lesion has scarring or not enough pigmentation, then the device can’t evaluate it. Therefore, a doctor must still be able to categorize those lesions appropriately without the device.

Right now, the device can be used only by board-certified dermatologists who undergo a specialized training course. MELA Sciences plans to distribute the device to 200 dermatologists on the East Coast next year. Doctors will pay a onetime fee of $7,500 to lease and receive training on the device, and patients must pay $150 out of pocket for a MelaFind scan — MELA Sciences doesn’t plan on asking insurers to chip in until several years from now, when the device is more widely used. But my guess is that insurance companies will be on board if they see that the device is reducing the massive expense of having to do biopsies and treat metastasized melanoma. In any case, if you have a tendency to develop suspicious moles and if you have a family history of melanoma, MelaFind is a major step in the right direction. “Hopefully this new device will help us all, but it is not yet the gold standard,” said Dr. Marmur. “If you have a spot that’s changing or concerning you, have your dermatologist take a look.”

Source:  Ellen Marmur, MD, skin cancer specialist and vice chair of dermatological and cosmetic surgery at the Mount Sinai Medical Center, New York City.

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