Head and Neck Neoplasms
Conditions
Keywords
Head and neck neoplasms, Fluorescence, Short Wave Infra-Red
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...
Interventions
DEVICEENDOSWIR
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.
Sponsors
Institute for Advanced Biosciences (IAB), Grenoble
Commissariat A L'energie Atomique
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection | 1 day | Concordance rate (in %) between the ENDOSWIR result and the final pathological examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis | 1 day | Time (in minutes) for ENDOSWIR data acquisition and processing. |
| Demonstration of the safety of SWIR. | 1 day | No perceptible tissue change on the SWIR exposed sample |
| Ancillary analysis of special interest areas | 1 day | 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 |
Contacts
Primary ContactChristian Righini, MD, PhD
Outcome results
None listed