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

Sponsor

SciBase AB (Other)

Overall Status

Recruiting

CT.gov ID

NCT06064019

Collaborator

(none)

150

Enrollment

Location

Arm

4.6

Anticipated Duration (Months)

32.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratinocyte Skin Cancer	Device: Nevisense	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Nevisense Sensitivity and Specificity [1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CentroDerm	Wuppertal		Germany

Sponsors and Collaborators

SciBase AB

Investigators

Principal Investigator: Thomas Dirschka, Prof. Dr. med., CentroDerm GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Dirschka, Prof Dr, CentroDerm GmbH

ClinicalTrials.gov Identifier:

NCT06064019

Other Study ID Numbers:

EIS-KC001

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Thomas Dirschka, Prof Dr, CentroDerm GmbH

Electrical Impedance Spectroscopy

Additional relevant MeSH terms:

Skin Neoplasms

Study Results

No Results Posted as of Oct 3, 2023