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

NCT02851693 | Withdrawn

• 2 other identifiers: 16080692016-A00647-44
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• implementation duration

  at baseline

• acquisition practices duration

  at baseline

• the duration of analysis image

  at baseline

• utility of labeling with a dye for histology to locate the lesion

  at baseline

Study Arms (1)

Optical Coherence Tomography (OCT)

EXPERIMENTAL

Device: Optical Coherence Tomography (OCT) with Vivosight; Device: Optical Coherence Tomography (OCT) with Skintell

Interventions

Optical Coherence Tomography (OCT) with Vivosight DEVICE

OCT used is Vivosight for diagnosis

Also known as: VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK)

Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) with Skintell DEVICE

OCT used is Skintell for diagnosis

Also known as: SKINTELL (Agfa HealthCare, Heverlee, Belgium)

Optical Coherence Tomography (OCT)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;
• pregnant and nursing women
• patients under tutorship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• National Research Agency, France: collaborator

MeSH Terms

Conditions

Mixed Tumor, Malignant; Carcinoma; Keratosis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Jean Luc PERROT, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 2, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share