Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

NCT07323966 | Recruiting

• 1 other identifier: 2025/25JUL/316
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

radiotherapy; brain tumor; mask; surface guidance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient's feelings with and without the mask

  Through the course of radiation therapy (up to 6 weeks)

• Preference of treatment

  Through the course of radiation therapy (up to 6 weeks)

Study Arms (1)

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.

Device: Surface Guided Radiation Therapy without mask

Interventions

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.

Radiotherapy session without mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years old
• Brain tumor treated with fractionated radiotherapy
• Able to read and complete a questionnaire in French

You may not qualify if:

• Inability to remain still

Sponsors & Collaborators

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

Study Sites (1)

Cliniques Universitaires Saint-Luc

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

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Masks

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Dario Di Perri

CONTACT

+32 2 764 47 52‬; dario.diperri@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 7, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)