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

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ClinicalTrials.gov Identifier: NCT03076255
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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
Brain and Nervous System Intracranial Neoplasm Head and Neck Cancer Procedure: Computed Tomography Device: Medical Device Procedure: Cone-Beam Computed Tomography Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 : February 24, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph [ Time Frame: 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)



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076255


Contacts
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Contact: Voichita Bar Ad, MD (215) 955-6702 Voichita.Bar-Ad@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Voichita Bar Ad, MD    215-955-6702      
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Voichita Bar Ad, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03076255     History of Changes
Other Study ID Numbers: 16D.557
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases