N/A
Completed N=12
Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors
Brain and Nervous System · Intracranial Neoplasm · Head and Neck Cancer
Source: ClinicalTrials.gov NCT03076255 ↗
Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Oct 2025
Primary outcomePrimary: Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph — 0.08; 0.16; -0.02 centimeters (cm)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph |
0.08; 0.16; -0.02 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03076255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.