Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

Study Overview
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Brief Summary
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The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution. The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques. The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin. Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques. However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.

Official Title
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Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

Conditions
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Mixed Tumor, Malignant, Biopsy, Resection, Carcinoma, Keratosis

Intervention / Treatment
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* Device: Optical Coherence Tomography (OCT) with Vivosight
* Device: Optical Coherence Tomography (OCT) with Skintell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision; consent signed Exclusion Criteria: Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements; pregnant and nursing women patients under tutorship or curatorship

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Coherence Tomography (OCT)<br> | Device: Optical Coherence Tomography (OCT) with Vivosight<br>* OCT used is Vivosight for diagnosis<br>* Other names: VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK);Device: Optical Coherence Tomography (OCT) with Skintell<br>* OCT used is Skintell for diagnosis<br>* Other names: SKINTELL (Agfa HealthCare, Heverlee, Belgium);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint | thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence) | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implementation duration | minutes | at baseline | 
| acquisition practices duration | minutes | at baseline | 
| the duration of analysis image | minutes | at baseline | 
| utility of labeling with a dye for histology to locate the lesion | yes or no | at baseline |