Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

Not Applicable

Withdrawn

• Conditions: Brain Cancer; Brain Diseases
• Interventions: Device: Wiersma Head Stabilizer; Device: AlignRT system

• Registration Number: NCT03629964
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-14
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Head stabilizer group	Wiersma Head Stabilizer	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.
Head stabilizer group	AlignRT system	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States