Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection (OCTSKIN)

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.

Study Overview

• Status: Withdrawn
• Conditions: Carcinoma; Keratosis; Biopsy; Mixed Tumor, Malignant; Resection
• Intervention / Treatment: Device: Optical Coherence Tomography (OCT) with Vivosight; Device: Optical Coherence Tomography (OCT) with Skintell

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: National Research Agency, France
• Investigators: Principal Investigator: Jean Luc PERROT, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Keratosis; Mixed Tumor, Malignant
• Other Study ID Numbers: 1608069; 2016-A00647-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No