Clinical trial NCT02851693: Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
Official title: Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mixed Tumor, Malignant
Biopsy
Resection
Carcinoma
Keratosis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2016-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: composite endpoint
timeFrame: at baseline
Secondary outcomes:
measure: implementation duration
timeFrame: at baseline
measure: acquisition practices duration
timeFrame: at baseline
measure: the duration of analysis image
timeFrame: at baseline
measure: utility of labeling with a dye for histology to locate the lesion
timeFrame: at baseline
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Jean Luc PERROT, MD
role: PRINCIPAL_INVESTIGATOR
References: