Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo

This will be a mThe surgeon will remove the tumour and collect frozen section according to his usual practices. He will then analyse the same areas on the specimen, or directly analyse the tissue sampled for the frozen section using the Dyameo device. The position of the analysis will be marked on the specimen by sutures. No results will be displayed on the screen at this stage, so as not to influence the doctor;s actions. The surgeon is also free to analyse additional areas with Dyameo device if he or she considers this to be of interest. After the operation, the pathology lab will analyze the tumor specimen to assess the margin status and evaluate the exact nature of the tissues on the localisation of frozen section/Dyameo analysis. Simultaneously, the results of the analyses carried out with the Dyameo device will be exported and analysed (blind to the results of the histological analysis), in order to determine the indications that would have been given to the surgeon during the operation.

The results obtained with the device will be compared with the results of the extemporaneous biopsy analysis. The postoperative histological analysis will serve as a reference.

The performance of the device will be measured by evaluating a posteriori the accuracy of the results provided, and therefore the accuracy of the instructions given to the surgeon during the operation (e.g. additional recutting in the event of the presence of residual tumour cells at the margin of the tumour specimen). The study will also make it possible to calculate sensitivity, specificity, precision, positive and negative predictive values, and relative risk for the device.

Inclusion criteria

• Confirmed diagnosis of squamous cell carcinoma of the oral cavity, pharynx and/or larynx
• Planned standard surgery with curative intent for squamous cell carcinoma
• Planned surgery includes the performance of extemporaneous biopsies
• Age ≥ 18 years
• Affiliation to a social security scheme

Exclusion criteria

• Medical or psychiatric conditions that compromise the patient's ability to understand the research in which he or she is participating
• Persons of full age subject to a legal protection measure (guardianship or curatorship) or unable to express their non-objection.
• Uncontrolled concomitant medical conditions
• Having received an investigational medicinal product in the 30 days prior to the operation
• History of treatment with anti-EGFR monoclonal antibodies.
• Previously demonstrated absence of EGFR expression by tumour cells.