To Biopsy, Or Not To Biopsy?

Jun 10, 2013 at 05:06 pm by steve

MelaFind® handheld device assesses lesions

MelaFind®  Sheds New Light On Melanoma Diagnosis

            Every hour, melanoma takes a life. The deadliest of skin cancers is increasing in incidence, and with the popularity of sunbathing and indoor tanning, more young people are among the 130,000 new cases diagnosed in the US each year.  

            “More than 75% of the deaths from skin cancer are due to melanoma,” said Gary Monheit, MD of Total Skin & Beauty Dermatology Center. “Diagnosed late, it can be lethal. But with early detection and treatment, melanoma is 99% curable.” 

            A past president of the American Society of Dermatologic Surgery, Monheit said one of the most important responsibilities of a dermatologist is diagnosing suspicious pigmented lesions to detect melanoma. The challenge comes in determining when a biopsy is warranted.

            “If we biopsy everything, we’ll find most melanomas. However, we’d also put a lot of patients through unnecessary pain and expense. With facial lesions, the risk of an unnecessary scar can also be a concern that may influence some patients to delay seeing their doctor,” Monheit said.

            That’s where the new MelaFind® noninvasive handheld device developed by MELA Sciences can help by giving physicians a clearer sense of when a biopsy is warranted. Monheit was involved in clinical trials of the technology which led to recent FDA approval. His office is now equipped with the first commercially available MelaFind device in Alabama.

            “We don’t use it on every lesion, but it gives us much more information to evaluate the quirky ones,” Monheit said. “With MelaFind, you can use up to ten different wavelengths to illuminate the area. Different spectra allow us to see pigment patterns below the surface at various depths.”

            The lens system uses nine elements and a photon light sensor to collect multispectral data from light scattered back from the skin. Automatic data analysis algorithms compare the information to a database of more than 10,000 biopsied atypical lesions. The patient’s lesion is then classified based on 3-D images showing high or low disorganization at different depths.

            “With the MelaFind system, we get objective data we can use to evaluate worrisome lesions. It helps us weed out those that don’t warrant biopsy and gives us independent data confirming those that do,” Monheit said.

            During FDA trials, the study compared the technology with visual assessment by experienced dermatologists to determine sensitivity and specificity. Both MelaFind and the dermatologists participating in the study scored well in sensitivity, correctly detecting more than 95% of the lesions that proved to be melanoma on biopsy. The big difference came in specificity, with MelaFind identifying twice as many lesions that were harmless and did not require biopsy.

            “When patients know they won’t automatically face a biopsy unless there is solid, objective evidence it is truly needed, they can feel more comfortable about coming in early to have suspicious lesions evaluated,” Monheit said. “We can also keep the data on file to watch a suspicious lesion that hasn’t turned into melanoma yet, so patients come back three months later for follow up to determine whether the lesion is evolving.”

At stage 0, 99% of melanomas can be cured. At stage 3, the five-year survival rate falls to 50%. At stage 4, only 25% of patients are still alive five years later. Does that mean that everyone needs to be proactively screened by a dermatologist for melanoma?

“All patients need to have their primary physician look over moles and skin changes using the ABCDEs of evaluation. Check for asymmetry, irregular borders, color variations, a large diameter and recent changes that show the lesion is evolving,” Monheit said.

Patients at higher risk may need to see a dermatologist for screening and evaluation of moles. This is particularly true if there is a history of melanoma in the family that might indicate a genetic predisposition, or other risk factors.

“Melanoma is more common in people with fair skin and light eyes, particularly in climates where there is a lot of sun,” Monheit said. “When patients have a history of sunburn, use indoor tanning, or if they have more than 50 moles, their risk for developing melanoma is higher. They should be aware of the need to watch for changes and to have any irregular or abnormal lesions evaluated promptly.

“As the number of new cases of melanoma continues to increase, physicians in coming years will find themselves facing the decision to biopsy or not to biopsy more often,” Monheit said. “With the MelaFind device, we have a tool to help us evaluate what a suspicious lesion is likely to be—and what it isn’t likely to be.”

Images of Dr. Monheit here: google Gary Monheit, MD Birmingham and click on images. Maybe one will work?


 




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