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

NCT06618170 | Not Yet Recruiting

• 1 other identifier: 2024-A01462-45
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical. It is essential to remove all tumour tissue while preserving as much of the surrounding healthy tissue as possible. Today, surgeons use frozen sections to confirm their decision. Dyameo has developed a device that can identify the presence of tumour markers on the surface of tissue in a matter of seconds, simply by placing the end of a fibre-optic probe in contact with the tissue. This device should enable the surgeon to identify the presence of tumour cells at the margin of the removed tumour. The aim of this study is to measure the performance of this device. The surgeon will carry out his operation according to his own routine. After collecting tissue for frozen section analysis, he will analyse the tumour specimen using the Dyameo device. After the operation, histological analysis of the removed tumour will enable the precision of the device to be measured and compared with that of the extemporaneous biopsies to guide the surgeon\'s intervention.

Conditions

Head and Neck Cancers

Keywords

guided surgery; head and neck; carcinoma; surgical margin

Outcome Measures

Primary Outcomes (1)

• Efficacy of the Dyameo device in guiding surgical procedures

  Proportion of cases where analysis with the Dyameo device has provided valid instructions to guide surgery (e.g. make an additional cut if tumour cells are present in at least one area of the resection margin)

  During the surgical intervention

Secondary Outcomes (1)

• Device performances

  During the surgical intervention

Interventions

Tissue surface analysis with the device DIAGNOSTIC_TEST

Usage of the device to analyse the presence or absence of tumoral membrane marker at the surface of the removed tumoral specimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with squamous cell carcinoma of head and neck for whom surgical removal requiring frozen section analysis is planned.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dyameo: lead
• GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou): collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexis Saintamand

CONTACT

+0033555782795; contact@dyameo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-09