Brain TumorMASKLESSNCT07323966
Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients
A study testing Surface Guided Radiation Therapy without mask in people with Brain Tumor, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Surface Guided Radiation Therapy without mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Nov 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Brain tumor treated with fractionated radiotherapy
- Able to read and complete a questionnaire in French
Who cannot join
- Inability to remain still
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200
Dario Di Perri
About this study
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.
Read the 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
- Being tested
- Surface Guided Radiation Therapy without mask
- Keywords
- radiotherapy, brain tumor, mask, surface guidance
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Guided Radiation Therapy without maskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy session without mask | Experimental | A radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions. Receives: Device: Surface Guided Radiation Therapy without mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the course of radiation therapy (up to 6 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through the course of radiation therapy (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start18 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323966
- Sponsor's protocol ID
- 2025/25JUL/316
- Acronym
- MASKLESS
- Status last verified
- Dec 2025
- First submitted
- 24 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT07323966
- Acronym / sponsor ID
- MASKLESS / 2025/25JUL/316
- Conditions
- Brain Tumor
- Keywords
- radiotherapy, brain tumor, mask, surface guidance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy session without mask | Experimental | Device: Surface Guided Radiation Therapy without maskA radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years old
- Brain tumor treated with fractionated radiotherapy
- Able to read and complete a questionnaire in French
Key exclusion criteria (1 listed)
- Inability to remain still
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Guided Radiation Therapy without maskPatients 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. | Device | Radiotherapy session without mask |
Primary outcome
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Guided Radiation Therapy without mask in people with Brain Tumor, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dario Di Perri (+32 2 764 47 52, dario.diperri@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of patient's position (time frame: Through the course of radiation therapy (up to 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.