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

Not Applicable

Completed

• Conditions: Brain and Nervous System; Intracranial Neoplasm; Head and Neck Cancer
• Interventions: Procedure: Computed Tomography; Device: Medical Device; Procedure: Cone-Beam Computed Tomography

• Registration Number: NCT03076255
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-24
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (MID)	Medical Device	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.
Supportive care (MID)	Computed Tomography	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.
Supportive care (MID)	Cone-Beam Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph	Up to 3 weeks	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)

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States