Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety

Malvehy, Josep; Hauschild, Axel; Curiel‐Lewandrowski, Clara; Mohr, Peter; Hofmann-Wellenhof, R; Motley, Richard; Berking, Carola; Grossman, Douglas; Paoli, John; Loquai, Carmen; Oláh, Judit; Reinhold, Uwe; Wenger, Harold; Dirschka, Thomas; Davis, Suraj V; Henderson, C. A.; Rabinovitz, Harold; Welzel, Julia; Schadendorf, Dirk; Birgersson, Ulrik

doi:10.1111/bjd.13121

Cited by 160 publications

(186 citation statements)

References 56 publications

(56 reference statements)

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“…In comparison, for discrimination between melanoma and benign pigmented lesions in a population of suspicious lesions, MelaFind conducted a clinical study involving 1,831 pigmented skin lesions, obtaining 98% sensitivity and 9% specificity [8], and Nevisense (SciBase AB, Stockholm, Sweden) employed a non-optical technique called electrical impedance spectroscopy in a clinical study involving 1,943 suspicious lesions, obtaining 96.6% sensitivity and 34.4% specificity for melanoma detection [20].…”

Section: Resultsmentioning

confidence: 99%

Optical detection and monitoring of pigmented skin lesions

Stamnes

Ryzhikov

Biryulina

et al. 2017

Biomed. Opt. Express

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A method is presented for discriminating between malignant and benign pigmented skin lesions based on multispectral and multi-angle images. It is discussed how to retrieve maps of physiology properties and morphometric parameters from recorded images using a biooptical model, radiative transfer calculations, and nonlinear inversion, and how to employ automated zooming to extract lesion and surrounding masks. Training and validation of a classification scheme for separation between benign and malignant tissue yielded sensitivity/specificity ranging from 97%/97% for application to a small dataset comprised of lesions not used for training and validation to 99%/93% for application to a larger dataset.

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Section: Resultsmentioning

confidence: 99%

Optical detection and monitoring of pigmented skin lesions

Stamnes

Ryzhikov

Biryulina

et al. 2017

Biomed. Opt. Express

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“…3 Electrical impedance spectroscopy (EIS) (Nevisense, SciBase AB, Stockholm, Sweden) has been shown to have potential as a diagnostic aid for the detection of melanoma. 4,5 In the current study, we examined a subset of data from an international, multicenter, trial 4 in order to compare the sensitivity of EIS to…”

Section: Original Researchmentioning

confidence: 99%

“…Of the 1,943 pigmented lesions evaluated in a prior series 4 , the 265 biopsy-proven melanoma lesions (112 in situ, 153 invasive melanoma) were selected for inclusion in this sub-analysis. Prior to excisional biopsy, using the EIS device, lesions had been measured on a 0-10 scale, with a score of 4 or greater representing a positive score.…”

Section: Introductionmentioning

confidence: 99%

“…This subgroup analysis of biopsy-proven melanoma lesions from the pivotal study examining the clinical performance a novel EIS system demonstrates that the false negative rate of EIS for the detection of melanoma is quite low, making this tool potentially useful as a method of ruling out malignancy in equivocal pigmented skin lesions. 4 Additionally, when combined with other adjunctive methods (as would be done in a real-world setting), EIS has the potential to increase sensitivity for detection of melanoma. However, it is important to remember that when combining two techniques such as EIS and dermoscopy, sensitivity for detection will increase relative to each individual technique at the cost of a lower combined specificity compared to each individual technique (because the number of false positive lesions will increase).…”

Section: Introductionmentioning

confidence: 99%

“…4,5 In the current study, we examined a subset of data from an international, multicenter, trial 4 in order to compare the sensitivity of EIS to…”

mentioning

confidence: 99%

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Electrical Impedance Spectroscopy Versus Clinical Inspection Approaches: Melanoma Efficacy Detection Comparison

Svoboda¹,

Franco²,

Rigel

2018

J of Skin

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Early detection and excision remain the most important prognostic factors in the treatment of melanoma.1 Detection remains challenging and, resultantly, melanomarelated mortality is high. In 2017, an estimated 9,730 people will die from melanoma in the United States.2 Accordingly, there has been significant interest in novel technologies aimed at augmenting the detection rate achieved with clinical diagnosis of melanoma.3 Electrical impedance spectroscopy (EIS) (Nevisense, SciBase AB, Stockholm, Sweden) has been shown to have potential as a diagnostic aid for the detection of melanoma. 4,5 In the current study, we examined a subset of data from an international, multicenter, trial 4 in order to compare the sensitivity of EIS to ABSTRACTEarly detection of melanoma continues to provide a diagnostic challenge for Dermatologists and other healthcare providers. Recently, there has been increased interest in the use of novel technology to aid in the detection of melanoma. We performed a post-hoc analysis of a subset of data from the Nevisense pivotal trial to retrospectively compare the results of one such technology-electrical impedance spectroscopy (EIS)-to existing melanoma detection tools in 265 cases of malignant melanoma. Lesions were analyzed using EIS, the clinical ABCD rule, the ABCD dermoscopy rule, and the standard and weighted melanoma 7-point checklists. The proportion of false negative cases was calculated for each method and correlation between EIS score and melanoma stage was calculated. Overall, EIS produced an acceptable false negative rate (3.4%) for the detection of melanoma. Additionally, there was a statistically significant, moderate correlation between EIS score and tumor staging (Spearman rho=0.32, p<0.001). In this sample, EIS was very sensitive for the detection of melanoma and may prove to be a useful clinical adjunct for ruling out malignant melanoma in challenging cases.

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Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy

Ferris

Jansen

et al. 2017

JAMA Dermatol

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he quest for strategies and tools that facilitate early detection of melanoma with high sensitivity and specificity remains a continuing effort. In 2 studies, 1,2 20% to 30% of early melanomas were initially undetected by dermatologists from academic institutions and practicing dermatologists experienced in managing pigmented lesions and familiar with dermoscopy. The inherent limitations of image recognition make the visual assessment of pigmented skin lesions challenging even for experienced dermatologists, and tools such as dermoscopy or computer-aided image analysis of skin lesions can reduce, but not overcome, these inherent limitations. 3 The established standard of care, which is to biopsy most suspicious lesions, is linked to many surgical biopsies. Various studies analyzing the number needed to treat (ie, the number of surgical biopsies obtained to detect a melanoma) have reported these values ranging from 8 for experienced dermoscopy users to 30 or more for other health care professionals. [4][5][6] A highly accurate, simple, noninvasive diagnostic modality is desired by health care professionals and patients.A large validation study including a total of 555 patients established that a noninvasive diagnostic modality, termed pigmented lesion assay (PLA; DermTech, Inc) and based on expression profiles of the long intergenic non-protein coding RNA 518 IMPORTANCE Expression of long intergenic non-protein coding RNA 518 (LINC00518) and preferentially expressed antigen in melanoma (PRAME) genes, obtained via noninvasive adhesive patch biopsy, is a sensitive and specific method for detection of cutaneous melanoma. However, the utility of this test in biopsy decisions made by dermatologists has not been evaluated.OBJECTIVE To determine the utility of the pigmented lesion assay (PLA) for LINC00518/PRAME expression in decisions to biopsy a series of pigmented skin lesions. DESIGN, SETTING, AND PARTICIPANTSIn this secure web-based, multiple-readermultiple-case study, 45 board-certified dermatologists each evaluated 60 clinical and dermoscopic images of clinically atypical pigmented lesions, first without and then with PLA gene expression information and were asked whether the lesions should be biopsied. Data were collected from March 24, 2014, through November 13, 2015.INTERVENTIONS Participants were given a report for each lesion, which included the results of an assay for expression of LINC00518/PRAME and a PLA score with data on the predictive values of the information provided. MAIN OUTCOMES AND MEASURESBiopsy sensitivity and specificity with vs without PLA data.RESULTS Forty-five dermatologists (29 male and 16 female) performed the evaluation. After incorporating the PLA into their decision as to whether to biopsy a pigmented lesion suggestive of melanoma, dermatologists improved their mean biopsy sensitivity from 95.0% to 98.6% (P = .01); specificity increased from 32.1% to 56.9% (P < .001) with PLA data. CONCLUSIONS AND RELEVANCEThe noninvasive PLA enables dermatologists to significantly improve biopsy s...

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Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety

Cited by 160 publications

References 56 publications

Optical detection and monitoring of pigmented skin lesions

Optical detection and monitoring of pigmented skin lesions

Electrical Impedance Spectroscopy Versus Clinical Inspection Approaches: Melanoma Efficacy Detection Comparison

Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy

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