Keratinocyte Skin Cancer
Conditions
Keywords
Electrical Impedance Spectroscopy
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.
Interventions
DEVICENevisense
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.
Sponsors
SciBase AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nevisense Sensitivity and Specificity | 1 year | 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 |
Countries
Germany
Contacts
Primary ContactPer Svedenhag
Outcome results
None listed