No-Mask radiation therapy: a comfortable alternative for head and neck cancer patients?
NCT ID NCT03076255
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a new maskless immobilization device (MID) for patients with head and neck cancers or brain tumors undergoing radiation therapy. The goal was to see if the device could keep patients as still and accurate as the standard thermoplastic mask. Only 12 patients were enrolled, and the study measured how much movement occurred during treatment. Results may lead to a more comfortable option for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Maskless immobilization device (MID)
- What this could lead to
- If successful, this device could offer a more comfortable alternative to thermoplastic masks for patients undergoing radiation therapy for head and neck cancers or brain tumors.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply to all patients. The device may not be as accurate or reliable as standard masks in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Feb 2017
- Finished
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Nov 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Five days of radiation instead of weeks: a new test for head and neck cancer
- Can an online program ease the burden on cancer caregivers?