Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

NCT ID: NCT03629964

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2019-10-01

Brief Summary

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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

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Conditions

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Brain Diseases Brain Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wiersma Head Stabilizer

Intervention Type DEVICE

Experimental device attached to treatment table.

AlignRT system

Intervention Type DEVICE

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.

Interventions

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Wiersma Head Stabilizer

Experimental device attached to treatment table.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodney Wiersma, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-0506

Identifier Type: -

Identifier Source: org_study_id

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