Trial results for a head and neck maskless immobilization device for patients with intracranial tumors and head and neck cancer were posted on ClinicalTrials.gov on 2025-10-15. The device demonstrated high accuracy, with mean translational shifts of 0.08 cm, 0.16 cm, and -0.02 cm.
Background
Radiation therapy for head and neck cancers and intracranial tumors requires precise patient immobilization to ensure accurate targeting and minimize damage to healthy tissue. Traditionally, thermoplastic masks are used for this purpose, but they can be uncomfortable for patients. A maskless immobilization device aims to provide comparable accuracy and reliability while potentially improving patient comfort during treatment.
Trial design
This completed pilot clinical trial (Phase NA) enrolled 12 participants. The study investigated the use of a head and neck maskless immobilization device for patients with conditions including Brain and Nervous System, Intracranial Neoplasm, and Head and Neck Cancer. The trial's objective was to assess how well the maskless device immobilizes patients undergoing radiation therapy, aiming for accuracy and reliability comparable to standard thermoplastic masks.
Key results
The trial measured the accuracy of the maskless immobilization device by quantifying the difference in translational shifts from the daily setup to the planning CT scan digitally reconstructed radiograph. For the Supportive care (MID) group, the key measurements were:
- Mean translational shift of 0.08 centimeters (cm) (Standard Deviation 0.30 cm).
- Mean translational shift of 0.16 centimeters (cm) (Standard Deviation 0.52 cm).
- Mean translational shift of -0.02 centimeters (cm) (Standard Deviation 0.47 cm).
What this means
The results indicate that the head and neck maskless immobilization device effectively limits patient movement during radiation therapy. The reported mean translational shifts, which are very small (0.08 cm, 0.16 cm, and -0.02 cm), suggest that the device provides a high level of accuracy in patient immobilization. This could offer a viable alternative to traditional thermoplastic masks, potentially enhancing patient comfort without compromising the precision required for radiation treatment in patients with head and neck cancers or intracranial tumors.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT03076255, titled "Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors", were posted on 2025-10-15 on clinicaltrials.gov.