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| Name | Class |
|---|---|
| Institute for Advanced Biosciences (IAB), Grenoble | UNKNOWN |
| Commissariat A L'energie Atomique | OTHER_GOV |
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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.
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...
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENT cancers | patients with ENT cancer in the active care line for who a surgical resection is planned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOSWIR | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Righini, MD, PhD | Contact | 0476765656 | crighini@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christian Righini, MD, PhD | CHU Grenoble Alpes | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25803186 | Result | 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. | |
| 30182451 | Result | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 31873212 | Result | 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. |
| 24895321 | Result | 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. |