RESUMO
We determine the in-vivo dielectric properties-resistivity and relative permittivity-of living epidermis and dermis of human skin soaked with a physiological saline solution for one minute between 1 kHz and 1 MHz. This is done by fitting approximate analytical solutions of a mechanistic model for the transport of charges in these layers to a training set comprising impedance measurements at two depth settings on stripped skin on the volar forearm of 24 young subjects. Here, the depth settings are obtained by varying the voltage at a second inject on the electrical-impedance-spectroscopy probe. The model and the dielectric properties are validated with a test set for a third depth setting with overall good agreement. In addition, the means and standard deviations of the thicknesses of living epidermis and dermis are estimated from a literature review as 61±7 µm and 1.0±0.2 mm respectively. Furthermore, extensions to resolve the skin layers in more detail are suggested.
RESUMO
An approximate semi-analytical solution based on a Hankel transform of a mechanistic model for electrical impedance spectroscopy (EIS) is derived for a non-invasive axisymmetric concentric probe with m electrodes measuring the response of n layers of human skin. We validate the semi-analytical solution for the case when the skin is treated as a three-layer entity - (i) stratum corneum, (ii) viable skin comprising living epidermis and dermis and (iii) adipose tissue - on the volar forearm in the frequency range 1 kHz to 1 MHz with experimental EIS measurements of 120 young subjects. Overall, we find good agreement for both the mean magnitude and phase of the impedance as well as the natural variability between subjects. Finally, the semi-analytical solution is verified with the full set of equations solved numerically: Good agreement is found for the point-wise potential distribution in the three skin layers.
RESUMO
BACKGROUND: Even though progress has been made, the detection of melanoma still poses a challenge. In light of this situation, the Nevisense electrical impedance spectroscopy (EIS) system (SciBase AB, Stockholm, Sweden) was designed and shown to have the potential to be used as an adjunct diagnostic tool for melanoma detection. OBJECTIVES: To assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy. METHODS: This multicentre, prospective, and blinded clinical study was conducted at five American and 17 European investigational sites. All eligible skin lesions in the study were examined with the EIS-based Nevisense system, photographed, removed by excisional biopsy and subjected to histopathological evaluation. A postprocedure clinical follow-up was conducted at 7 ± 3 days from the initial measurement. A total of 1951 patients with 2416 lesions were enrolled into the study; 1943 lesions were eligible and evaluable for the primary efficacy end point, including 265 melanomas - 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0·57 mm [48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs)]. RESULTS: The observed sensitivity of Nevisense was 96·6% (256 of 265 melanomas) with an exact one-sided 95% lower confidence bound estimated at 94·2% and an observed specificity of 34·4%, and an exact two-sided 95% confidence bound estimated at 32·0-36·9%. The positive and negative predictive values of Nevisense were 21·1% and 98·2%, respectively. The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) with an exact two-sided 95% confidence bound estimated at 93·5-100·0%. CONCLUSIONS: Nevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma.
