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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Intracranial Neoplasm; Brain and Nervous System; Head and Neck Cancer

Treatments: Device: Medical Device; Procedure: Cone-Beam Computed Tomography; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT03076255

JT 8994 (Other Identifier)

16D.557

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Supportive care (MID)

Experimental group

Description:

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.

Treatment:

Procedure: Computed Tomography

Procedure: Cone-Beam Computed Tomography

Device: Medical Device

Device: Medical Device