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

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Enrolling

Conditions

Brain Tumor

Treatments

Device: Surface Guided Radiation Therapy without mask

Study type

Interventional

Funder types

Other

Identifiers

NCT07323966
2025/25JUL/316

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Radiotherapy session without mask
Experimental group
Description:
A radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions.
Treatment:
Device: Surface Guided Radiation Therapy without mask

Trial contacts and locations

1

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Central trial contact

Dario Di Perri

Data sourced from clinicaltrials.gov

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