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

• Conditions: Head and Neck Neoplasms
• Interventions: Device: ENDOSWIR

• Registration Number: NCT05318872
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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...

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Study Start: 2022-04-11
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-09-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ENT cancers	ENDOSWIR	patients with ENT cancer in the active care line for who a surgical resection is planned.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Demonstration of the safety of SWIR.	1 day	No perceptible tissue change on the SWIR exposed sample
Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis	1 day	Time (in minutes) for ENDOSWIR data acquisition and processing.
Ancillary analysis of special interest areas	1 day	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