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Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07323966
Acronym
MASKLESS
Enrollment
20
Registered
2026-01-07
Start date
2025-11-18
Completion date
2026-06-30
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Keywords

radiotherapy, brain tumor, mask, surface guidance

Brief summary

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

DEVICESurface 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.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stability of patient's positionThrough the course of radiation therapy (up to 6 weeks)The stability of the patient's position will be assessed: * on the basis of internal movements (of the skull) detected by scanner imaging before and after the simulated session (on-board CBCT) * on the basis of surface movements monitored by SGRT throughout the session.

Secondary

MeasureTime frameDescription
Patient's feelings with and without the maskThrough the course of radiation therapy (up to 6 weeks)Patients are asked to fill in a questionnaire about their feelings (comfort, anxiety, claustrophobia, isolation, pain) during radiotherapy sessions with a mask and simulated sessions without an immobilization mask.
Preference of treatmentThrough the course of radiation therapy (up to 6 weeks)Patients are asked to indicate whether they prefer to be treated with or without a mask.

Countries

Belgium

Contacts

Primary ContactDario Di Perri
dario.diperri@saintluc.uclouvain.be+32 2 764 47 52‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026