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Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV) (DERMOCTAV)

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ClinicalTrials.gov Identifier: NCT05340543
Recruitment Status : Recruiting
First Posted : April 22, 2022
Last Update Posted : April 22, 2022
Sponsor:
Collaborator:
European Clinical Trial Experts Network
Information provided by (Responsible Party):
Ramsay Générale de Santé

Study Description
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Brief Summary:
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

Condition or disease Intervention/treatment
Cutaneous Tumor Optical Coherence Tomography Basal Cell Carcinoma Squamous Cell Carcinoma Melanoma Procedure: Confocal optical coherence tomography - OCTAVE

Detailed Description:

There are mainly 3 types of skin cancer: melanoma, basal cell carcinoma and squamous cell carcinoma. The diagnosis of skin cancers is now based on anatomo-pathological evidence. However, given the progress made, imaging is a technique that now has a full role in the diagnosis of these pathologies. This is particularly the case of confocal optical coherence tomography (LC-OCT), which is a recent imaging technique that has proven itself in ophthalmology with the obtaining of precise images of the retina.

LC-OCT can be applied in dermatology according to the following principle: the low intensity laser beam delivered by the LC-OCT device interferes with the melanin, is reflected and makes it possible to instantly acquire a 3D cross-sectional image of the skin, with a resolution of the order of a micrometer. It is finally an "optical echography", the light allowing a tissue definition much higher than the ultrasonic waves. It is therefore possible to obtain sections of histological resolution, and to scan the entire area studied.

Based on this principle, DAMAE has created OCTAV®, a class 1 medical device intended to allow "an in-depth study of skin pathologies", which is currently being evaluated in vivo as part of a clinical trial ( OCTAV - NCT03731247).

The device evaluated in the OCTAV trial does not include the "dermoscope" function. However, coupled with an image capture and processing system, it would increase the magnification obtained from 10 times to 20 or 30 times, allowing precise targeting of the lesion. As a result, a new prototype of OCTAV® has been developed which integrates the "dermoscope" function.

In this context, this project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : June 16, 2022
Estimated Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Skin Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient with basal cell carcinoma
- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels.
 Procedure: Confocal optical coherence tomography - OCTAVE
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
Patient with squamous cell carcinoma
- CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels
 Procedure: Confocal optical coherence tomography - OCTAVE
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
Patient with melanoma
Melanoma: Destructured dermal-epidermal junction (DEJ), presence of pagetoid cells, clusters of atypical melanocytes, dendritic cells
 Procedure: Confocal optical coherence tomography - OCTAVE
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function


Outcome Measures
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Primary Outcome Measures :
  1. Concordance RATE [ Time Frame: 10 days ]
    Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
Criteria

Inclusion Criteria:

  • Patient, male or female, at least 18 years old
  • Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
  • Affiliated patient or beneficiary of a social security scheme
  • Patient having signed the free and informed consent

Exclusion Criteria:

  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding women
  • Patient hospitalized without consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05340543


Contacts
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Contact: Jean francois OUDET 0683346567 jf.oudet@ecten.eu
Contact: Marie-Hélène Barba mh.barba@ecten.eu

Locations
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France
Hôpital Privé d'Antony Antony Recruiting
Antony, IDF, France, 92160
Contact: Pierre-André BECHEREL, Dr    +33668645429    pierre-andre.becherel@ramsaysante.fr   
Contact: Marie Barba    +330664888704 ext +330664888704    mh.barba@ecten.eu   
Principal Investigator: pierre-andre becherel, Dr         
Sponsors and Collaborators
Ramsay Générale de Santé
European Clinical Trial Experts Network
Investigators
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Study Chair: DRE RAMSAYGDS Ramsay Générale de Santé
More Information
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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT05340543    
Other Study ID Numbers: 2019-A02609-48
First Posted: April 22, 2022    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases