Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

NCT03629964 | Withdrawn FDA Device

• 1 other identifier: IRB17-0506
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Diseases; Brain Cancer

Outcome Measures

Primary Outcomes (1)

• Access feasibility of the use of an experimental head stabilizer device

  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

  During radiation treatment (5-10 days)

Study Arms (1)

Head stabilizer group

EXPERIMENTAL

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.

Device: Wiersma Head Stabilizer; Device: AlignRT system

Interventions

Wiersma Head Stabilizer DEVICE

Experimental device attached to treatment table.

Head stabilizer group

AlignRT system 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.

Head stabilizer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Brain Diseases; Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Rodney Wiersma, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 14, 2018
• Study Start: July 16, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

US (1)