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

Head and Neck Cancer Clinical Trial

Official title:

A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076255
• Other study ID #: 16D.557
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: November 3, 2020

Study information

• Verified date: August 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain and Nervous System
• Brain Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Intracranial Neoplasm

Intervention

Procedure:
• Computed Tomography
Undergo CT simulation

Device:
• Medical Device
Given thermoplastic mask
• Medical Device
Given MID

Procedure:
• Cone-Beam Computed Tomography
Undergo CBCT imaging

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph	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)	Up to 3 weeks

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital