Clinical performance of the Nevisense system in cutaneous melanoma detection

An international, multicentre, prospective and blinded clinical trial on efficacy and safety

J. Malvehy, A. Hauschild, Clara N Curiel, P. Mohr, R. Hofmann-Wellenhof, R. Motley, C. Berking, D. Grossman, J. Paoli, C. Loquai, J. Olah, U. Reinhold, H. Wenger, T. Dirschka, S. Davis, C. Henderson, H. Rabinovitz, J. Welzel, D. Schadendorf, U. Birgersson

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1099-1107
Number of pages9
JournalBritish Journal of Dermatology
Volume171
Issue number5
DOIs
StatePublished - Nov 1 2014

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Melanoma
Clinical Trials
Dielectric Spectroscopy
Safety
Skin
Electric Impedance
Basal Cell Carcinoma
Squamous Cell Carcinoma
Equipment and Supplies
Skin Neoplasms
Sweden
Prospective Studies
Biopsy

ASJC Scopus subject areas

  • Dermatology

Cite this

Clinical performance of the Nevisense system in cutaneous melanoma detection : An international, multicentre, prospective and blinded clinical trial on efficacy and safety. / Malvehy, J.; Hauschild, A.; Curiel, Clara N; Mohr, P.; Hofmann-Wellenhof, R.; Motley, R.; Berking, C.; Grossman, D.; Paoli, J.; Loquai, C.; Olah, J.; Reinhold, U.; Wenger, H.; Dirschka, T.; Davis, S.; Henderson, C.; Rabinovitz, H.; Welzel, J.; Schadendorf, D.; Birgersson, U.

In: British Journal of Dermatology, Vol. 171, No. 5, 01.11.2014, p. 1099-1107.

Research output: Contribution to journalArticle

Malvehy, J, Hauschild, A, Curiel, CN, Mohr, P, Hofmann-Wellenhof, R, Motley, R, Berking, C, Grossman, D, Paoli, J, Loquai, C, Olah, J, Reinhold, U, Wenger, H, Dirschka, T, Davis, S, Henderson, C, Rabinovitz, H, Welzel, J, Schadendorf, D & Birgersson, U 2014, 'Clinical performance of the Nevisense system in cutaneous melanoma detection: An international, multicentre, prospective and blinded clinical trial on efficacy and safety', British Journal of Dermatology, vol. 171, no. 5, pp. 1099-1107. https://doi.org/10.1111/bjd.13121
Malvehy, J. ; Hauschild, A. ; Curiel, Clara N ; Mohr, P. ; Hofmann-Wellenhof, R. ; Motley, R. ; Berking, C. ; Grossman, D. ; Paoli, J. ; Loquai, C. ; Olah, J. ; Reinhold, U. ; Wenger, H. ; Dirschka, T. ; Davis, S. ; Henderson, C. ; Rabinovitz, H. ; Welzel, J. ; Schadendorf, D. ; Birgersson, U. / Clinical performance of the Nevisense system in cutaneous melanoma detection : An international, multicentre, prospective and blinded clinical trial on efficacy and safety. In: British Journal of Dermatology. 2014 ; Vol. 171, No. 5. pp. 1099-1107.
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title = "Clinical performance of the Nevisense system in cutaneous melanoma detection: An international, multicentre, prospective and blinded clinical trial on efficacy and safety",
abstract = "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.",
author = "J. Malvehy and A. Hauschild and Curiel, {Clara N} and P. Mohr and R. Hofmann-Wellenhof and R. Motley and C. Berking and D. Grossman and J. Paoli and C. Loquai and J. Olah and U. Reinhold and H. Wenger and T. Dirschka and S. Davis and C. Henderson and H. Rabinovitz and J. Welzel and D. Schadendorf and U. Birgersson",
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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, Clara N

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.

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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