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

NCT03076255 | Completed Results FDA Device

• 2 other identifiers: 16D.557JT 8994
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain and Nervous System; Intracranial Neoplasm; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to Day 15, an average of 31 days

Study Arms (1)

Supportive care (MID)

EXPERIMENTAL

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; Device: Medical Device; Procedure: Cone-Beam Computed Tomography

Interventions

Computed Tomography PROCEDURE

Undergo CT simulation

Also known as: CAT Scan, CAT, Computerized Axial Tomography

Supportive care (MID)

Medical Device DEVICE

Given thermoplastic mask

Supportive care (MID)

Cone-Beam Computed Tomography PROCEDURE

Undergo CBCT imaging

Supportive care (MID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Neurologic Manifestations; Brain Neoplasms; Head and Neck Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Voichita Bar-Ad, MD
• Organization: Thomas Jefferson University

Voichita.BarAd@jefferson.edu

215-955-6702

Study Officials

• Voichita Bar Ad, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: February 24, 2017
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Locations

US (1)