Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Chicago
- Locations
- 1
- Primary Endpoint
- Access feasibility of the use of an experimental head stabilizer device
Study Overview
Brief Summary
The purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (SRS). SRS is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. This study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. The investigators would like to first see how the experimental device works in whole brain radiation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.
Exclusion Criteria
- Not provided
Arms & Interventions
Head stabilizer group
Patients will be receiving standard brain radiation. The experimental head holder device (called the Wiersma Head Stabilizer) will be attached to treatment table and will make small movements to adjust the position of the head in response to movement by the patient. In addition, the AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the patient's head moves beyond a set distance) will be used to track real-time motions of the head. This system is used with radiation therapy as standard of care.
Intervention: Wiersma Head Stabilizer (Device)
Head stabilizer group
Patients will be receiving standard brain radiation. The experimental head holder device (called the Wiersma Head Stabilizer) will be attached to treatment table and will make small movements to adjust the position of the head in response to movement by the patient. In addition, the AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the patient's head moves beyond a set distance) will be used to track real-time motions of the head. This system is used with radiation therapy as standard of care.
Intervention: AlignRT system (Device)
Outcomes
Primary Outcomes
Access feasibility of the use of an experimental head stabilizer device
Time Frame: During radiation treatment (5-10 days)
Feasibility will be defined as to whether or not the 6D target is ≤ 0.5mm and ≤ 0.5deg for greater than 95% of treatment time
Secondary Outcomes
No secondary outcomes reported