Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surface Guided Radiation Therapy without mask.
- Who it may be relevant to
- Registry conditions: Brain Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is to investigate the technical feasibility of brain radiotherapy without immobilization masks using surface imaging to ensure accurate patient positioning and continuous motion monitoring.
Detailed description
In brain radiotherapy, immobilization using a thermoplastic mask is a standard practice to ensure treatment accuracy. However, this method causes discomfort and anxiety for patients. The development of surface imaging (Surface Guided Radiation Therapy, SGRT) could offer a solution to this problem. SGRT is a non-invasive and non-ionizing imaging technique that uses cameras to capture the patient's position in real-time. In mask-free treatment, the radiation beam can be interrupted when motion exceeds a certain threshold and restarts only when the position is corrected.
Nowadays, very few studies have examined the concept of radiation therapy without immobilization masks using SGRT.
As part of this study, participants will take part in a simulated mask-free session. We will determine the stability of the patient's position in the absence of a mask. Participants will also complete questionnaires concerning their feelings during sessions with and without masks.
Interventions
- Device Surface Guided Radiation Therapy without mask
Patients are positioned using SGRT based on the reference position reconstructed from the simulation scanner. They are asked to remain still during the typical duration of a conventional radiotherapy session. Patient motion is monitored by SGRT throughout the simulated session. A CBCT scan is performed before and after the session. No treatment is delivered.
Primary outcome measures
- Stability of patient's position [Time frame: Through the course of radiation therapy (up to 6 weeks)]
Secondary outcome measures (2)
- Patient's feelings with and without the mask [Time frame: Through the course of radiation therapy (up to 6 weeks)]
- Preference of treatment [Time frame: Through the course of radiation therapy (up to 6 weeks)]
Eligibility criteria
Inclusion criteria
- Age >= 18 years old
- Brain tumor treated with fractionated radiotherapy
- Able to read and complete a questionnaire in French
Exclusion criteria
- Inability to remain still
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
Identifiers
NCT: NCT07323966 · 2025/25JUL/316