Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

The University of Chicago

Status: Withdrawn

Conditions: Brain Cancer; Brain Diseases

Treatments: Device: Wiersma Head Stabilizer; Device: AlignRT system

Study type: Interventional

Funder types: Other

Identifiers

NCT03629964

IRB17-0506

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Head stabilizer group

Experimental group

Description:

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.

Treatment:

Device: AlignRT system

Device: Wiersma Head Stabilizer