Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

Brain Cancer Clinical Trial

Official title:

Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03629964
• Other study ID #: IRB17-0506
• Status: Withdrawn
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Diseases
• Brain Neoplasms

Intervention

Device:
• Wiersma Head Stabilizer
Experimental device attached to treatment table.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During radiation treatment (5-10 days)