Clinical trial NCT05318872: Prospective Evaluation of ENDOSWIR Device Versus Pathology for Squamous Cell Carcinoma of Upper Aerodigestive Tract (ENDOSWIR-VADS)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Neoplasms
Keywords: Head and neck neoplasms
Fluorescence
Short Wave Infra-Red
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institute for Advanced Biosciences (IAB), Grenoble
name: Commissariat A L'energie Atomique
First posted: 2022-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is selected from the subjects operated on for ENT carcinoma in a programmed manner and as part of the management at the CHUGA.

The active file of the CHUGA for an exeresis of squamous cell carcinoma of the oral cavity or oropharynx is about 1 subject per week which should allow to finalize the project in 6 months by supposing that it will be possible to include 50% of the subjects.

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...

Eligibility criteria: 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.

Primary outcomes:
measure: Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection
timeFrame: 1 day
Secondary outcomes:
measure: Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis
timeFrame: 1 day
measure: Demonstration of the safety of SWIR.
timeFrame: 1 day
measure: Ancillary analysis of special interest areas
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: CHU Grenoble Alpes
name: Christian Righini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson RH, Nadeau KP, Jaworski FB, Tromberg BJ, Durkin AJ. Review of short-wave infrared spectroscopy and imaging methods for biological tissue characterization. J Biomed Opt. 2015 Mar;20(3):030901. doi: 10.1117/1.JBO.20.3.030901.
citation: Kenry, Duan Y, Liu B. Recent Advances of Optical Imaging in the Second Near-Infrared Window. Adv Mater. 2018 Nov;30(47):e1802394. doi: 10.1002/adma.201802394. Epub 2018 Sep 4.
citation: Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23.
citation: Schols RM, ter Laan M, Stassen LP, Bouvy ND, Amelink A, Wieringa FP, Alic L. Differentiation between nerve and adipose tissue using wide-band (350-1,830 nm) in vivo diffuse reflectance spectroscopy. Lasers Surg Med. 2014 Sep;46(7):538-45. doi: 10.1002/lsm.22264. Epub 2014 Jun 4.