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Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

Sponsor
University of Chicago (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03629964
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
14.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wiersma Head Stabilizer
  • Device: AlignRT system
 N/A

Study Design

Study Type:
Interventional
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 :
Jul 16, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Access feasibility of the use of an experimental head stabilizer device [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Medical Center Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Rodney Wiersma, PhD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT03629964
Other Study ID Numbers:
  • IRB17-0506
First Posted:
Aug 14, 2018
Last Update Posted:
May 8, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases

Study Results

No Results Posted as of May 8, 2020