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Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629964
Recruitment Status : Withdrawn (PI left site.)
First Posted : August 14, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Brain Diseases Brain Cancer Device: Wiersma Head Stabilizer Device: AlignRT system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Diseases

Arm Intervention/treatment
Experimental: 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.
Device: Wiersma Head Stabilizer
Experimental device attached to treatment table.

Device: AlignRT system
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 Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629964


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Rodney Wiersma, PhD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03629964    
Other Study ID Numbers: IRB17-0506
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Diseases
Nervous System Diseases