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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)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05340543
Acronym
DERMOCTAV
Enrollment
150
Registered
2022-04-22
Start date
2021-12-16
Completion date
2022-06-16
Last updated
2022-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma, Cutaneous Tumor, Melanoma, Optical Coherence Tomography, Squamous Cell Carcinoma

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.

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.

Interventions

PROCEDUREConfocal optical coherence tomography - OCTAVE

An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the dermoscope function

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concordance RATE10 daysCorrelation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.

Countries

France

Contacts

Primary ContactJean francois OUDET
jf.oudet@ecten.eu0683346567
Backup ContactMarie-Hélène Barba
mh.barba@ecten.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026