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

NCT06064019 | Recruiting

• 1 other identifier: EIS-KC001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratinocyte Skin Cancer

Keywords

Electrical Impedance Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Nevisense Sensitivity and Specificity

  This study has two primary endpoints: 1. Sensitivity ≥ 0.90 2. 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

Study Arms (1)

Nevisense

OTHER

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

Interventions

Nevisense DEVICE

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.

Nevisense

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SciBase AB: lead

Study Sites (1)

CentroDerm

Wuppertal, Germany

RECRUITING

Study Officials

• Thomas Dirschka, Prof. Dr. med.

  CentroDerm GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Svedenhag

CONTACT

+46 8410 620 01; per.svedenhag@scibase.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 3, 2023
• Study Start: July 13, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

DE (1)