Clinical trial · Interventional
Closed vs. Open Face Masks for Cranial Radiotherapy
Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
NCT04079595CI-TRIAL-00077427completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 partial cranial radiotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Head immobilization mask | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Open-faced head immonbilization masks
- description
- Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face
- interventionNames
- Device: Head immobilization mask
- type
- ACTIVE_COMPARATOR
- label
- Closed-face head immobilization masks
- description
- Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed
- interventionNames
- Device: Head immobilization mask
Primary outcomes (2)
- measure
- Patient discomfort with the two immobilization masks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.