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

NCT02851693 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-04-04

No results posted yet for this study

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

Interventions

DEVICE

Optical Coherence Tomography (OCT) with Vivosight

OCT used is Vivosight for diagnosis

DEVICE

Optical Coherence Tomography (OCT) with Skintell

OCT used is Skintell for diagnosis

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Jean Luc PERROT, MD · Centre Hospitalier Universitaire de Saint Etienne

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-12-01
Completion
2017-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02851693 on ClinicalTrials.gov