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Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03629964
Enrollment
0
Registered
2018-08-14
Start date
2018-07-16
Completion date
2019-10-01
Last updated
2020-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Brain Diseases

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.

Interventions

DEVICEWiersma Head Stabilizer

Experimental device attached to treatment table.

DEVICEAlignRT 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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Access feasibility of the use of an experimental head stabilizer deviceDuring 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026