Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

NCT ID: NCT07323966

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-18
• Study Completion Date: 2026-06-30

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Radiotherapy session without mask

A radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions.

Group Type: EXPERIMENTAL

Surface Guided Radiation Therapy without mask

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Dario Di Perri

Role: CONTACT

dario.diperri@saintluc.uclouvain.be

+32 2 764 47 52‬

Other Identifiers

2025/25JUL/316

Identifier Type: -

Identifier Source: org_study_id