Back to resultsHead and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
Primary Purpose
Brain and Nervous System, Intracranial Neoplasm, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Medical Device
Medical Device
Cone-Beam Computed Tomography
Sponsored by
About this trial
This is an interventional supportive care trial for Brain and Nervous System
Eligibility 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)
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (MID)
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03076255
First Posted
March 6, 2017
Last Updated
August 31, 2021
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03076255
Brief Title
Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Nervous System, Intracranial Neoplasm, Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (MID)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT Scan, CAT, Computerized Axial Tomography
Intervention Description
Undergo CT simulation
Intervention Type
Device
Intervention Name(s)
Medical Device
Intervention Description
Given thermoplastic mask
Intervention Type
Device
Intervention Name(s)
Medical Device
Intervention Description
Given MID
Intervention Type
Procedure
Intervention Name(s)
Cone-Beam Computed Tomography
Intervention Description
Undergo CBCT imaging
Primary Outcome Measure Information:
Title
Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph
Description
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)
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Voichita Bar Ad, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
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