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NCT Number: NCT07323966

Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location status: Recruiting

Location contact

Dario Di Perri

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surface Guided Radiation Therapy without mask

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.

Primary outcomes

  1. Stability of patient's position

    Time frame: Through 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 outcomes

  1. Patient's feelings with and without the mask

    Time frame: Through 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.

  2. Preference of treatment

    Time frame: Through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dario Di Perri

CONTACT

[email protected]

+32 2 764 47 52‬

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: MASKLESS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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