To excise or not: impact of MelaFind on German dermatologists' decisions to biopsy atypical lesions.

OBJECTIVES: To determine the biopsy sensitivity to melanoma of dermatologists in Germany and the impact of MelaFind® on their decisions to biopsy melanomas. DESIGN: Randomized two-armed online reader study presenting case information, clinical/dermatoscopic images of pigmented skin lesions and MelaFind results (Arm 2). METHODS: Each participant was asked to review 130 pigmented skin lesions. Biopsy decisions of dermatologists without MelaFind versus MelaFind and dermatologists without MelaFind versus dermatologists with MelaFind were compared. RESULTS: Dermatologists without MelaFind had average sensitivity to melanoma of 69.5 % and average specificity of 55.9 %. MelaFind had greater sensitivity than dermatologists alone (96.9 % vs. 69.5 %, one-sided p < 0.00001) and lower specificity (9.2 % vs. 55.9 %, one-sided p < 0.00001). Dermatologists with MelaFind had higher sensitivity than those without MelaFind (78 % vs. 69.5 %, one-sided p < 0.00001) and a lower specificity (45.8 % vs. 55.9 %, one-sided p < 0.00001). The number of dermatologists detecting over 90 % of melanomas increased from 3 of 101 without MelaFind to 22 of 101 with MelaFind (p = 0.00006) while specificity remained relatively equivalent (23 % vs. 21 %, p = 0.99). CONCLUSIONS: The MelaFind information, when incorporated into the final biopsy decision, can improve biopsy sensitivity with modest effect on biopsy specificity.

The performance of MelaFind: a prospective multicenter study.

OBJECTIVE: To demonstrate the safety and effectiveness of MelaFind, a noninvasive and objective computer-vision system designed to aid in detection of early pigmented cutaneous melanoma. DESIGN: A prospective, multicenter, blinded study. The diagnostic performance of MelaFind and of study clinicians was evaluated using the histologic reference standard. Standard images and patient information for a subset of 50 randomly selected lesions (25 melanomas) were used in a reader study of 39 independent dermatologists to estimate clinicians' biopsy sensitivity to melanoma. SETTING: Three academic and 4 community practices in the United States with expertise in management of pigmented skin lesions. PATIENTS: A total of 1383 patients with 1831 lesions enrolled from January 2007 to July 2008; 1632 lesions (including 127 melanomas-45% in situ-with median Breslow thickness of invasive lesions, 0.36 mm) were eligible and evaluable for the study end points. MAIN OUTCOME MEASURES: Sensitivity of MelaFind; specificities and biopsy ratios for MelaFind and the study investigators; and biopsy sensitivities of independent dermatologists in the reader study. RESULTS: The measured sensitivity of MelaFind was 98.4% (125 of 127 melanomas) with a 95% lower confidence bound at 95.6% and a biopsy ratio of 10.8:1; the average biopsy sensitivity of dermatologists was 78% in the reader study. Including borderline lesions (high-grade dysplastic nevi, atypical melanocytic proliferations, or hyperplasias), MelaFind's sensitivity was 98.3% (172 of 175), with a biopsy ratio of 7.6:1. On lesions biopsied mostly to rule out melanoma, MelaFind's average specificity (9.9%) was superior to that of clinicians (3.7%) (P=.02). CONCLUSION: MelaFind is a safe and effective tool to assist in the evaluation of pigmented skin lesions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00434057.

The diagnostic performance of expert dermoscopists vs a computer-vision system on small-diameter melanomas.

OBJECTIVE: To evaluate the performance of dermoscopists in diagnosing small pigmented skin lesions (diameter

Utility of lesion diameter in the clinical diagnosis of cutaneous melanoma.

OBJECTIVE: To determine the utility of the current diameter criterion of larger than 6 mm of the ABCDE acronym for the early diagnosis of cutaneous melanoma. DESIGN: Cohort study. SETTING: Dermatology hospital-based clinics and community practice offices. Patients A total of 1323 patients undergoing skin biopsies of 1657 pigmented lesions suggestive of melanoma. MAIN OUTCOME MEASURE: The maximum lesion dimension (diameter) of each skin lesion was calculated before biopsy using a novel computerized skin imaging system. RESULTS: Of 1657 biopsied lesions, 853 (51.5%) were 6 mm or smaller in diameter. Invasive melanomas were diagnosed in 13 of 853 lesions (1.5%) that were 6 mm or smaller in diameter and in 41 of 804 lesions (5.1%) that were larger than 6 mm in diameter. In situ melanomas were diagnosed in 22 of 853 lesions (2.6%) that were 6 mm or smaller in diameter and in 62 of 804 lesions (7.7%) that were larger than 6 mm in diameter. Conclusion The diameter guideline of larger than 6 mm provides a useful parameter for physicians and should continue to be used in combination with the A, B, C, and E criteria previously established in the selection of atypical lesions for skin biopsy.

Kinetic model of progression of cutaneous melanoma population.

A kinetic model for progression of a population of cutaneous melanomas through categories defined by the range of Breslow thickness, with melanomas in situ (MIS) in category 0, and melanomas with Breslow thickness > or =2 mm in category 3, is described. The model assumes that all melanomas start out in category 0; this category is further subdivided into indolent and progressing melanomas. Steady-state solutions for the distributions of excised melanomas were found. Depending on the proportion of indolent MIS, these solutions predict very different distributions of excised melanomas and melanoma mortality, when either frequency of examinations by physicians or sensitivity to melanoma is changed. Although it is not currently possible to differentiate between indolent and progressing MIS either clinically or histologically, solutions of this kinetic model can be used to determine the proportion of such indolent lesions in a population-based study. The steady-state solutions of the kinetic model can be used to analyze melanoma progression in any stable patient population, in which the total number of melanomas detected per year is either stable or varies slowly. As an example, melanoma progression is analyzed using the American Cancer Society estimates of melanoma incidence and mortality. For a fixed incidence rate, melanoma mortality and melanoma treatment cost in the USA could be significantly reduced by increasing the biopsy sensitivity of physicians to in-situ and thin-invasive melanomas.