NCT05318872

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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...

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DEVICE	ENDOSWIR	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.

Timeline

• Start date: 2022-04-11
• Primary completion: 2022-09-30
• Completion: 2023-06-30
• First posted: 2022-04-08
• Last updated: 2022-04-12