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

NCT ID: NCT02851693

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-12-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Optical Coherence Tomography (OCT)

Group Type: EXPERIMENTAL

Optical Coherence Tomography (OCT) with Vivosight

Intervention Type: DEVICE

OCT used is Vivosight for diagnosis

Optical Coherence Tomography (OCT) with Skintell

Intervention Type: DEVICE

OCT used is Skintell for diagnosis

Interventions

Optical Coherence Tomography (OCT) with Vivosight

OCT used is Vivosight for diagnosis

Intervention Type: DEVICE

Optical Coherence Tomography (OCT) with Skintell

OCT used is Skintell for diagnosis

Intervention Type: DEVICE

Other Intervention Names

VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK); SKINTELL (Agfa HealthCare, Heverlee, Belgium)

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Luc PERROT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Other Identifiers

2016-A00647-44

Identifier Type: OTHER

Identifier Source: secondary_id

1608069

Identifier Type: -

Identifier Source: org_study_id