ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Withdrawn

Conditions

Mixed Tumor, Malignant
Keratosis
Biopsy
Carcinoma
Resection

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02851693
1608069
2016-A00647-44 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Optical Coherence Tomography (OCT)
Experimental group
Treatment:
Device: Optical Coherence Tomography (OCT) with Skintell
Device: Optical Coherence Tomography (OCT) with Vivosight

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems