search
Back to results

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

Primary Purpose

Keratinocyte Skin Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nevisense
Sponsored by
SciBase AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Keratinocyte Skin Cancer focused on measuring Electrical Impedance Spectroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CentroDermRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nevisense

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2023
Last Updated
September 28, 2023
Sponsor
SciBase AB
search

1. Study Identification

Unique Protocol Identification Number
NCT06064019
Brief Title
Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
Official Title
Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SciBase AB

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratinocyte Skin Cancer
Keywords
Electrical Impedance Spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nevisense
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nevisense
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nevisense Sensitivity and Specificity
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Svedenhag
Phone
+46 8410 620 01
Email
per.svedenhag@scibase.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dirschka, Prof. Dr. med.
Organizational Affiliation
CentroDerm GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CentroDerm
City
Wuppertal
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Dirschka, Prof.Dr.med.
First Name & Middle Initial & Last Name & Degree
Lutz Schmitz, Priv.-Doz.Dr.med

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs