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

Not Applicable

Withdrawn

• Conditions: Resection; Mixed Tumor, Malignant; Biopsy; Carcinoma; Keratosis
• Interventions: Device: Optical Coherence Tomography (OCT) with Vivosight; Device: Optical Coherence Tomography (OCT) with Skintell

• Registration Number: NCT02851693
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT) with Vivosight	-
Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT) with Skintell	-

Primary Outcome Measures

Name	Time	Method
composite endpoint	at baseline	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)

Secondary Outcome Measures

Name	Time	Method
the duration of analysis image	at baseline	minutes
utility of labeling with a dye for histology to locate the lesion	at baseline	yes or no
implementation duration	at baseline	minutes
acquisition practices duration	at baseline	minutes