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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT03076255
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
44.3
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Device: Medical Device
  • Device: Medical Device
  • Procedure: Cone-Beam Computed Tomography
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Feb 24, 2017
Actual Primary Completion Date :
Nov 3, 2020
Actual Study Completion Date :
Nov 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Computed Tomography
Undergo CT simulation
Other Names:
  • CAT Scan
  • CAT
  • Computerized Axial Tomography

    • Device: Medical Device
    Given thermoplastic mask

    Device: Medical Device
    Given MID

    Procedure: Cone-Beam Computed Tomography
    Undergo CBCT imaging

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Investigators

    • Principal Investigator: Voichita Bar Ad, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03076255
    Other Study ID Numbers:
    • 16D.557
    First Posted:
    Mar 10, 2017
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Brain Neoplasms

    Study Results

    No Results Posted as of Sep 1, 2021