An observational study in Cutaneous Tumor, Optical Coherence Tomography and Basal Cell Carcinoma, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Ramsay Générale de Santé · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 150 is close to the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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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
Exclusion Criteria:
- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels.
Procedure: Confocal optical coherence tomography - OCTAVE
- CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels
Procedure: Confocal optical coherence tomography - OCTAVE
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
Concordance RATE
Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.
Time frame: 10 days
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Ramsay Générale de Santé