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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2020-11-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain and Nervous System Intracranial Neoplasm Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (MID)

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT simulation

Medical Device

Intervention Type DEVICE

Given thermoplastic mask

Medical Device

Intervention Type DEVICE

Given MID

Cone-Beam Computed Tomography

Intervention Type PROCEDURE

Undergo CBCT imaging

Interventions

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Computed Tomography

Undergo CT simulation

Intervention Type PROCEDURE

Medical Device

Given thermoplastic mask

Intervention Type DEVICE

Medical Device

Given MID

Intervention Type DEVICE

Cone-Beam Computed Tomography

Undergo CBCT imaging

Intervention Type PROCEDURE

Other Intervention Names

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CAT Scan CAT Computerized Axial Tomography

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No