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

Head and Neck Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05318872
• Other study ID #: 38RC22.0028
• Status: Not yet recruiting
• Start date: April 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Grenoble
• Contact: Christian Righini, MD, PhD
• Phone: 0476765656
• Email: crighini[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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...

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Commissariat A L'energie Atomique, Institute for Advanced Biosciences (IAB), Grenoble

References & Publications (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-infrare — View 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. Review. — View 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 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Demonstration of the safety of SWIR.	No perceptible tissue change on the SWIR exposed sample	1 day
Secondary	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