Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)
NCT ID: NCT05340543
Last Updated: 2022-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2021-12-16
2022-06-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with basal cell carcinoma
\- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels.
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
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
Confocal optical coherence tomography - OCTAVE
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
Interventions
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Confocal optical coherence tomography - OCTAVE
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breastfeeding women
* Patient hospitalized without consent
18 Years
ALL
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Principal Investigators
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DRE RAMSAYGDS
Role: STUDY_CHAIR
Ramsay Générale de Santé
Locations
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Hôpital Privé d'Antony Antony
Antony, IDF, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A02609-48
Identifier Type: -
Identifier Source: org_study_id
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