Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer

Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer

This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.

All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.

Study Overview

• Status: Recruiting
• Conditions: Keratinocyte Skin Cancer
• Intervention / Treatment: Device: Nevisense

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Svedenhag; Phone Number: +46 8410 620 01; Email: per.svedenhag@scibase.com

Study Locations

• Germany
  • Wuppertal, Germany
    • Recruiting
    • CentroDerm
    • Principal Investigator: Thomas Dirschka, Prof.Dr.med.
    • Sub-Investigator: Lutz Schmitz, Priv.-Doz.Dr.med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)

Exclusion Criteria:

• Metastases of recurrent lesions
• Lesion located on acral skin, e.g. sole or palm
• Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
• Lesion on hair-covered areas, e.g. scalp, beards, moustaches
• Lesion located on genitalia
• Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized
• Lesion located on mucosal surfaces
• Lesion with foreign matter, e.g. tattoo or splinter
• Lesion and / or reference located on acute sunburn
• Skin surface not measurable, e.g. lesion on a stalk
• Skin surface not accessible, e.g. inside ears, under nails

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Nevisense; This will be a prospective investigator-initiated study to evaluate the accuracy of Nevisense for KC. First evaluation steps include dermatologist's clinical examination (visual inspection) and videodermoscopy. In those cases where the routine diagnostic procedures given above identify any suspicion of a KC, a Nevisense measurement is to be conducted after examination of inclusion and exclusion criteria. Thereafter, surgical excision and histopathologic examination follow. All skin lesions with a suspicion of BCC, iSCC, BD or AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study. A maximum of three lesions per patient will be allowed for the study. The study aims to enrol 250 lesions in total.

Device: Nevisense; The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nevisense Sensitivity and Specificity	This study has two primary endpoints: Sensitivity ≥ 0.90; Sensitivity + Specificity > 1.0 Sensitivity is the proportion of correctly identified cases of KC. Specificity is the proportion of correctly identified cases of non-KC	1 year

Collaborators and Investigators

• Sponsor: SciBase AB
• Investigators: Principal Investigator: Thomas Dirschka, Prof. Dr. med., CentroDerm GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Electrical Impedance Spectroscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin Neoplasms
• Other Study ID Numbers: EIS-KC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No