Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042, France
Location status: Recruiting
NCT Number: NCT06627075
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rennes, Brittany Region, 35042, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion, an average of 1 year
Average length of linear translation vector during session (measured by surface cameras) over all sessions performed
Contact information is provided by the study sponsor or research team.
Center Eugene Marquis
Other
Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
Acronym: SUGAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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