RESUMEN
Background: Skin cancer is the most common form of cancer worldwide. As artificial intelligence (AI) expands its scope within dermatology, leveraging technology may aid skin cancer detection. Objective: To assess the safety and effectiveness of an elastic-scattering spectroscopy (ESS) device in evaluating lesions suggestive of skin cancer. Methods: This prospective, multicenter clinical validation study was conducted at 4 US investigational sites. Patients with skin lesions suggestive of melanoma and nonmelanoma skin cancers were clinically assessed by expert dermatologists and evaluated by a device using AI algorithms comparing current ESS lesion readings with training data sets. Statistical analyses included sensitivity, specificity, AUROC, negative predictive value (NPV), and positive predictive value (PPV). Results: Overall device sensitivity was 97.04%, with subgroup sensitivity of 96.67% for melanoma, 97.22% for basal cell carcinoma, and 97.01% for squamous cell carcinoma. No statistically significant difference was found between the device and dermatologist performance (P = .8203). Overall specificity of the device was 26.22%. Overall NPV of the device was 89.58% and PPV was 57.54%. Conclusion: The ESS device demonstrated high sensitivity in detecting skin cancer. Use of this device may assist primary care clinicians in assessing suspicious lesions, potentially reducing skin cancer morbidity and mortality through expedited and enhanced detection and intervention.
RESUMEN
Skin cancer is the most prevalent cancer, and its assessment remains a challenge for physicians. This study reports the application of an optical sensing method, elastic scattering spectroscopy (ESS), coupled with a classifier that was developed with machine learning, to assist in the discrimination of skin lesions that are concerning for malignancy. The method requires no special skin preparation, is non-invasive, easy to administer with minimal training, and allows rapid lesion classification. This novel approach was tested for all common forms of skin cancer. ESS spectra from a total of 1307 lesions were analyzed in a multi-center, non-randomized clinical trial. The classification algorithm was developed on a 950-lesion training dataset, and its diagnostic performance was evaluated against a 357-lesion testing dataset that was independent of the training dataset. The observed sensitivity was 100% (14/14) for melanoma and 94% (105/112) for non-melanoma skin cancer. The overall observed specificity was 36% (84/231). ESS has potential, as an adjunctive assessment tool, to assist physicians to differentiate between common benign and malignant skin lesions.
Asunto(s)
Neoplasias Cutáneas/diagnóstico , Neoplasias Cutáneas/patología , Análisis Espectral/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Piel/patologíaRESUMEN
Schamberg's disease is a pigmented purpuric dermatosis that is generally asymptomatic, however, patients with Schamberg's disease often seek treatment for aesthetic improvement. Many topical and systemic therapies have been tried without consistent results. This case series describes the treatment of five patients with Schamberg's disease of the lower extremities using Advanced Fluorescence Technology (AFT) pulsed light with favorable results.