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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection
研究概览
简要总结
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.
详细描述
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...
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection
时间窗: 1 day
Concordance rate (in %) between the ENDOSWIR result and the final pathological examination.
次要结局
- Demonstration of the safety of SWIR.(1 day)
- Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis(1 day)
- Ancillary analysis of special interest areas(1 day)