Brain and Nervous SystemNCT03076255
Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors
A study testing Computed Tomography, Medical Device and Cone-Beam Computed Tomography in people with Brain and Nervous System and Intracranial Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Nervous System, Intracranial Neoplasm, Head and Neck Cancer
- What is being tested?
- Computed Tomography, Medical Device and Cone-Beam Computed Tomography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
- Being tested
- Computed Tomography, Medical Device, Cone-Beam Computed Tomography
- Medical subject headings
- Neurologic Manifestations, Brain Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT Scan, CAT, Computerized Axial Tomography
Undergo CT simulation
Medical DeviceDevice
Given thermoplastic mask
Medical DeviceDevice
Given MID
Cone-Beam Computed TomographyProcedure or surgery
Undergo CBCT imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Device: Medical Device; Procedure: Cone-Beam Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 15, an average of 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start24 Feb 2017
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain and Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Voichita Bar Ad, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076255
- Sponsor's protocol ID
- 16D.557
- Other IDs
- JT 8994
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2017
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03076255
- Acronym / sponsor ID
- 16D.557
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (MID) | Experimental | Procedure: Computed Tomography, Device: Medical Device, Procedure: Cone-Beam Computed TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT Scan, CAT, Computerized Axial TomographyUndergo CT simulation | Procedure or surgery | Supportive care (MID) |
| Medical DeviceGiven thermoplastic mask | Device | Supportive care (MID) |
| Medical DeviceGiven MID | Device | Supportive care (MID) |
| Cone-Beam Computed TomographyUndergo CBCT imaging | Procedure or surgery | Supportive care (MID) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Voichita Bar Ad, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Medical Device and Cone-Beam Computed Tomography in people with Brain and Nervous System and Intracranial Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.