Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy SECONDARY OBJECTIVES: I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.

Official Title
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A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors

Conditions
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Brain and Nervous System, Intracranial Neoplasm, Head and Neck Cancer

Intervention / Treatment
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* Procedure: Computed Tomography
* Device: Medical Device
* Device: Medical Device
* Procedure: Cone-Beam Computed Tomography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (MID)<br>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. | Procedure: Computed Tomography<br>* Undergo CT simulation<br>* Other names: Computerized Axial Tomography;Device: Medical Device<br>* Given thermoplastic mask<br>Device: Medical Device<br>* Given MID<br>Procedure: Cone-Beam Computed Tomography<br>* Undergo CBCT imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph | The magnitude of the single vector that depicts the degree of setup discrepancy from CT simulation will be collected for each patient on each day the MID is applied (for both the thermoplastic mask and the MID) | Up to 3 weeks |