NCT06627075

Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.

Detailed description

In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients. At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted. However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras. The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.

Conditions

• Otorhinolaryngeal Cancer

Interventions

Type	Name	Description
PROCEDURE	Surface Guided RadioTherapy (SGRT) without mask	Firstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan. During the treatment sessions, patients are positioned according to the reference scan, using the surface camera system. Once the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (\>3 mm). If the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research. Patients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist.

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-10-12
• Completion: 2027-01-12
• First posted: 2024-10-04
• Last updated: 2025-02-13

Locations

1 site across 1 country: France