Back to resultsStudy to Develop Head Stabilizer for Use During Brain Radiation Therapy
Primary Purpose
Brain Diseases, Brain Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wiersma Head Stabilizer
AlignRT system
Sponsored by
About this trial
This is an interventional device feasibility trial for Brain Diseases
Eligibility Criteria
Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Head stabilizer group
Arm Description
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.
Outcomes
Primary Outcome Measures
Access feasibility of the use of an experimental head stabilizer device
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03629964
Brief Title
Study to Develop Head Stabilizer for Use During Brain Radiation Therapy
Official Title
Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI left site.
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases, Brain Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Head stabilizer group
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Wiersma Head Stabilizer
Intervention Description
Experimental device attached to treatment table.
Intervention Type
Device
Intervention Name(s)
AlignRT system
Intervention Description
The AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the 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.
Primary Outcome Measure Information:
Title
Access feasibility of the use of an experimental head stabilizer device
Description
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
Time Frame
During radiation treatment (5-10 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Wiersma, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study to Develop Head Stabilizer for Use During Brain Radiation Therapy
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