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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03076255
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT simulation
  • Medical Device — DEVICE
    Given thermoplastic mask
  • Medical Device — DEVICE
    Given MID
  • Cone-Beam Computed Tomography — PROCEDURE
    Undergo CBCT imaging

Study Details

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.

Key Dates

Start date
Feb 24, 2017
Status verified
Sep 2025
Primary completion
Nov 3, 2020
Completion
Nov 3, 2020

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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