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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Device: ENDOSWIR

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Christian Righini, MD, PhD; Phone Number: 0476765656; Email: crighini@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ENT cancers; patients with ENT cancer in the active care line for who a surgical resection is planned.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Commissariat A L'energie Atomique; Institute for Advanced Biosciences (IAB), Grenoble
• Investigators: Principal Investigator: Christian Righini, MD, PhD, Chu Grenoble Alpes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 11, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fluorescence; Head and neck neoplasms; Short Wave Infra-Red
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell
• Other Study ID Numbers: 38RC22.0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No