Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients (MASKLESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Device: Surface Guided Radiation Therapy without mask

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dario Di Perri; Phone Number: +32 2 764 47 52‬; Email: dario.diperri@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels Capital
    • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
      • Recruiting
      • Cliniques universitaires Saint-Luc
      • Principal Investigator: Dario Di Perri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability of patient's position	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.	Through the course of radiation therapy (up to 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's feelings with and without the mask	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.	Through the course of radiation therapy (up to 6 weeks)
Preference of treatment	Patients are asked to indicate whether they prefer to be treated with or without a mask.	Through the course of radiation therapy (up to 6 weeks)

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: radiotherapy; brain tumor; mask; surface guidance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Protective Devices; Personal Protective Equipment; Surgical Attire; Equipment and Supplies, Hospital; Masks
• Other Study ID Numbers: 2025/25JUL/316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No