Trials / Completed
CompletedNCT03076255
Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors
A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo CT simulation |
| DEVICE | Medical Device | Given thermoplastic mask |
| DEVICE | Medical Device | Given MID |
| PROCEDURE | Cone-Beam Computed Tomography | Undergo CBCT imaging |
Timeline
- Start date
- 2017-02-24
- Primary completion
- 2020-11-03
- Completion
- 2020-11-03
- First posted
- 2017-03-10
- Last updated
- 2025-10-15
- Results posted
- 2025-10-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03076255. Inclusion in this directory is not an endorsement.