Clinical trial · Interventional
Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors
A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors
- 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)
This pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. Maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.
Conditions
Conditions (3)
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 and Nervous System | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Cone-Beam Computed Tomography | Procedure | — | UNRESOLVED |
| Medical Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (MID)
- description
- Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15.
- interventionNames
- Procedure: Computed Tomography
- Device: Medical Device
- Procedure: Cone-Beam Computed Tomography
Primary outcomes (1)
- measure
- Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph
- timeFrame
- Baseline to Day 15, an average of 31 days
- description
- The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time * Age ≥ 18 years old * Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf * Provide signed and dated informed consent form Exclusion Criteria * History of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the RT planning process * Patient requires a neck brace for medical reasons * Skull or bony defect in the area contacting the immobilization straps * RT delivered by clinical setup only (no CT simulation)
References
Publications (0)
Data not yet available