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OpenTrials
Completed

NCT Number: NCT03076255

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

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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Key information

Conditions

Brain and Nervous System Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Head and Neck Cancer Head and Neck Neoplasms Intracranial Neoplasm Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Computed Tomography

Procedure

Undergo CT simulation

Other names: CAT Scan, CAT, Computerized Axial Tomography

Medical Device

Device

Given thermoplastic mask

Cone-Beam Computed Tomography

Procedure

Undergo CBCT imaging

Primary outcomes

  1. Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph

    Time frame: Baseline to Day 15, an average of 31 days

    The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2017
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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