Prospective Evaluation of ENDOSWIR Device Versus Pathology for Squamous Cell Carcinoma of Upper Aerodigestive Tract (ENDOSWIR-VADS)

Study Overview
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Brief Summary
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A new medical optical device named ENDOSWIR is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ENT squamous cell cancers.

Detailed Description
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In vivo short infrared imaging is a real-time, sensitive technique that can be used in the operating room during surgical removal of tumors. It is essential in the surgery of cancers of the upper aerodigestive tract to be in healthy margins in order to avoid heavier surgical resumption or complementary treatments such as radiotherapy. The optical imaging device in the short infrared range called ENDOSWIR and tested on tonsil samples has shown its safety on the analysis of tissues and seems to be promising for the detection of tumor tissues or, on the contrary, their absence in the resection margins (animal studies). The principal objective is to determine the ability of the ENDOSWIR DM-DIV to distinguish healthy tissue from tumor tissue on an ENT squamous cell carcinoma specimen by Concordance rate (in %) between the ENDOSWIR result and the final pathology examination of each tissue portion of a subject (8 per subject).. secondary objectives are : to demonstrate that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis, the safety of SWIR. An ancillary analysis of areas of particular interest such as resection margins or carcinoma in situ/dysplasia areas etc...

Official Title
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Preliminary Evaluation of the Analytical Performance of the ENDOSWIR Medical Device (DM-DIV) Versus Anatomical Pathology Examination in Patients Operated for Squamous Cell Carcinoma of Upper Aerodigestive Tract: Prospective Pilot Study

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Device: ENDOSWIR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ENT cancer (buccal or oropharyngeal) for which a surgical resection is planned affiliated to the social security Having given his non-opposition to participate in the trial. Exclusion Criteria: Patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint). Patients who have received radiotherapy treatment in the VADS area Patient with a history of VADS cancer or a synchronous location of VADS cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ENT cancers<br>patients with ENT cancer in the active care line for who a surgical resection is planned. | Device: ENDOSWIR<br>* Patients were enrolled for surgery of their cancer and give their consents to the participation to that study. Characteristics of anonymized patient (sex, age, medical history, and tumoral characteristics) will be collected. During surgery, the excisional specimen will be sent in a fresh state for pathological examination (gold standard). The pathologist will determine 10 zones on a cross-section of the specimen which will be analyzed by SWIR, and compared between the two techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection | Concordance rate (in %) between the ENDOSWIR result and the final pathological examination. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis | Time (in minutes) for ENDOSWIR data acquisition and processing. | 1 day | 
| Demonstration of the safety of SWIR. | No perceptible tissue change on the SWIR exposed sample | 1 day | 
| Ancillary analysis of special interest areas | Concordance rate and descriptive qualitative analysis between the ENDOSWIR result and the final pathological examination of tissue portions located in a subject's areas of special interest | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck neoplasms, Fluorescence, Short Wave Infra-Red