Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 motio

Первичные конечные точки

• Measurement patient displacement during surface-guided radiotherapy sessions [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Patients over 18 years of age
• Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
• Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
• Patients who have dated and signed an informed consent form

Критерии исключения

• Patients with uncontrollable movements
• Patients under psychiatric care
• Patients who do not understand or read French
• Patients participating in an interventional study testing another medical intervention
• Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
• Pregnant or breast-feeding women
• Patients without social security coverage

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre de Lutte contre le Cancer Eugène Marquis — Rennes

Идентификаторы

NCT: NCT06627075 · 2023-4-74-003 · 2023-A02324-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗