Status:
COMPLETED
Closed vs. Open Face Masks for Cranial Radiotherapy
Lead Sponsor:
University of Zurich
Conditions:
Brain Tumor
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or p...
Detailed Description
Upon randomization, patients will be begin treatment either with an open-face mask (A) or closed mask (B). Two individual immobilization masks - the open-face and closed masks - will be fabricated for...
Eligibility Criteria
Inclusion
- Written informed consent according to Swiss law and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before any trial specific procedures;
- Indication for cranial radiotherapy irrespective of tumor type;
- Age: ≥ 18 years old;
- Karnofsky performance status ≥70;
- Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
Exclusion
- Cranial radiotherapy in less than 10 fractions;
- Prior brain irradiation;
- Inability to complete magnetic resonance imaging (MRI) procedure due to claustrophobic anxiety;
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the course of the trial;
- Lack of safe contraception;
- Known or suspected non-compliance, drug or alcohol abuse
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04079595
Start Date
December 9 2019
End Date
May 31 2022
Last Update
May 23 2024
Active Locations (1)
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1
Department of Radiation Oncology
Zurich, Switzerland, 8091