NCT03629964

Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Diseases
• Brain Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2018-08-14
• Last updated: 2020-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study