Clinical trial · Interventional
Comparing Immobilisation Shells in Cranial Radiotherapy
A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
- 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)
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells. Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Brain Metastases | — | UNRESOLVED | — |
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Brain Tumor - Metastatic | — | UNRESOLVED | — |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A: Closed-face shell | Device | — | UNRESOLVED |
| Group B: Open-face shell | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A: Closed-face shells
- description
- Cranial radiotherapy using the control closed-face immobilisation shell.
- interventionNames
- Device: Group A: Closed-face shell
- type
- EXPERIMENTAL
- label
- Group B: open-face shell
- description
- Cranial radiotherapy using the experimental open-face immobilisation shell
- interventionNames
- Device: Group B: Open-face shell
Primary outcomes (1)
- measure
- Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with: * 5 or more fractions of virtually simulated cranial radiotherapy * treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions Exclusion Criteria: * patients unable to give informed consent * patients requiring conformal or inverse-planned radiotherapy * patients requiring stereotactic radiotherapy * patients who have previously had cranial or head and neck radiotherapy
References
Publications (0)
Data not yet available