N/A N=12 Supportive Care

Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors

Brain and Nervous System · Intracranial Neoplasm · Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03076255 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Oct 2025

Primary outcome: 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 centimeters (cm)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Computed Tomography (Procedure); Medical Device (Device); Cone-Beam Computed Tomography (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Primary completion: Nov 2020

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.