TY - JOUR
T1 - Clinical performance of the Nevisense system in cutaneous melanoma detection
T2 - An international, multicentre, prospective and blinded clinical trial on efficacy and safety
AU - Malvehy, J.
AU - Hauschild, A.
AU - Curiel-Lewandrowski, C.
AU - Mohr, P.
AU - Hofmann-Wellenhof, R.
AU - Motley, R.
AU - Berking, C.
AU - Grossman, D.
AU - Paoli, J.
AU - Loquai, C.
AU - Olah, J.
AU - Reinhold, U.
AU - Wenger, H.
AU - Dirschka, T.
AU - Davis, S.
AU - Henderson, C.
AU - Rabinovitz, H.
AU - Welzel, J.
AU - Schadendorf, D.
AU - Birgersson, U.
N1 - Publisher Copyright:
© 2014 British Association of Dermatologists.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Summary 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. What's already known about this topic? Although progress has been made in the detection of melanoma it still poses a challenge. Electrical impedance spectroscopy (EIS) may potentially be used as a diagnostic aid for the detection of melanoma. What does this study add? In the largest international prospective study of its kind in melanoma detection, the EIS system Nevisense was shown to be both accurate and safe in the lesion cohort studied. In the absence of a perfect gold standard, the accuracy of a device should be compared with the consensus diagnosis from multiple experts.
AB - Summary 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. What's already known about this topic? Although progress has been made in the detection of melanoma it still poses a challenge. Electrical impedance spectroscopy (EIS) may potentially be used as a diagnostic aid for the detection of melanoma. What does this study add? In the largest international prospective study of its kind in melanoma detection, the EIS system Nevisense was shown to be both accurate and safe in the lesion cohort studied. In the absence of a perfect gold standard, the accuracy of a device should be compared with the consensus diagnosis from multiple experts.
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U2 - 10.1111/bjd.13121
DO - 10.1111/bjd.13121
M3 - Article
C2 - 24841846
AN - SCOPUS:84911448090
SN - 0007-0963
VL - 171
SP - 1099
EP - 1107
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 5
ER -