Key points

Introduction

Over the past several decades, there have been many advances in the development of noninvasive technologies that facilitate the early detection of cutaneous melanoma. The use of dermoscopy and total body photography are established modalities proven to enhance the clinical evaluation of pigmented skin lesions at the level of the skin surface. Multispectral analysis devices take advantage of the variable penetration depths of isolated wavelengths of light to assess for pigmented lesion disorganization at different levels of the skin from the surface down to the superficial dermis. Pigmented skin lesion morphology is analyzed via computerized algorithms that measure morphologic disorganization using either melanin alone or in conjunction with hemoglobin and collagen as chromophores.

Introduction

Over the past several decades, there have been many advances in the development of noninvasive technologies that facilitate the early detection of cutaneous melanoma. The use of dermoscopy and total body photography are established modalities proven to enhance the clinical evaluation of pigmented skin lesions at the level of the skin surface. Multispectral analysis devices take advantage of the variable penetration depths of isolated wavelengths of light to assess for pigmented lesion disorganization at different levels of the skin from the surface down to the superficial dermis. Pigmented skin lesion morphology is analyzed via computerized algorithms that measure morphologic disorganization using either melanin alone or in conjunction with hemoglobin and collagen as chromophores.

Content

Multispectral digital skin lesion analysis (MSDSLA; MelaFind, STRATA Skin Sciences Inc., Horsham, PA) is a medical device that uses visible and near infrared light (430–950 nm) to image pigmented skin lesions at and up to 2.5 mm below the skin surface. Complex computerized analysis uses 75 unique analytical parameters to measure the degree of melanin disorganization within a pigmented skin lesion at 10 different spectral bandwidths. Originally validated on a set of 1432 pigmented lesions with subsequent logistical regression analysis, MSDSLA provides the clinician with the probability the suspicious pigmented skin lesion is a melanoma, and melanoma, high-grade dysplastic nevus, and atypical melanocytic hyperplasia.

Monheit and colleagues used MSDSLA alone to evaluate 1632 suspicious pigmented lesions for biopsy, of which 127 were melanoma. The sensitivity of MSDSLA for the detection of melanoma was 98% with a specificity of 11% in recognizing lower risk lesions. In this primarily university-based study, a low disorganization finding was associated with a 98% negative predictive value. However, the frequency and distribution of pigmented lesions that are encountered at high-risk pigmented lesion clinics would be expected to be different than what is experienced in a community-based setting. A subsequent study evaluating the efficacy of MSDSLA in a community-based setting revealed a negative predictive value of 100%.

The influence of MSDSLA on practitioner decisions to biopsy suspicious pigmented skin lesions has been studied in 7 reader studies including 855 practitioners. Participants were shown a subset of 62 clinical (distant and close-up) and dermoscopic images of pigmented skin lesions (13 invasive melanomas, 10 melanomas in situ, 7 high-grade dysplastic nevi, and 32 benign skin lesions including low-grade dysplastic nevi) previously analyzed by MSDSLA. Aggregated data revealed the overall sensitivity for the detection of melanoma or other high-grade pigmented lesion improved from 70% after clinical evaluation to 88% after MSDSLA information was provided ( P <.001). Participant specificity increased from 52% to 58% ( P <.001) after MSDSLA and diagnostic accuracy improved from 59% to 69% ( P <.001) with MSDSLA ( Table 1 ).

Table 1

Studies reviewed and aggregated showing impact of MSDSLA on melanoma diagnosis

Study, Year	n a	Sensitivity (%)		Specificity (%)		Biopsy Accuracy (%)
		Clinical Evaluation	After MSDSLA	Clinical Evaluation	After MSDSLA	Clinical Evaluation	After MSDSLA
Rigel et al, 2012	179	69	94	43	25	—	—
Yoo et al, 2013	126	52	77	54	40	—	—
Winkelmann et al, 2015	67	67	92	37	57	49	71
Winkelmann et al, 2015	41	64	62	57	73	60	68
Winkelmann et al, 2015	212	65	83	40	76	52	80
Winkelmann et al, 2016	59	59	74	48	56	53	65
Farberg et al, in press	160	76	92	52	79	64	86
Aggregate	855	70	88	52	58	59	69

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