Head Stabilization in Whole Brain RT

Real-Time Head Stabilization of Patients Undergoing Radiation Therapy

This is a single-center, single-arm observational study in which the investigators aim to develop an advanced motion control system for head stabilization in patients undergoing whole brain radiation therapy.

Study Overview

• Status: Withdrawn
• Conditions: Brain Cancer
• Intervention / Treatment: Device: Freedom Pursuit Robotic Platform

Detailed Description

Standard of care treatment is to be immobilized with a mask for whole brain radiation therapy. The purpose of this study is to develop a process to track and correct a person's head movements in real time during radiation treatment. To do this, the investigators will use a mask and head holder connected to a robotic support platform which can make small movements of the head holder.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 and older undergoing whole brain radiation therapy
• Participants must sign the informed consent form

Exclusion Criteria:

All patients not meeting the above inclusion criteria will not be considered for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Head Stabilization; Real-time patient head stabilization during radiation therapy will be performed using a specially designed patient mask and head holder that are connected to a robotic patient support platform (Freedom Pursuit Robotic Platform, CDR Systems, Canada) that will use real-time 3D surface data from the AlignRT system (3D surface imager) as an input and will perform small sub-millimeter corrections.

Device: Freedom Pursuit Robotic Platform; The Freedom Pursuit Robotic Platform is a robotic head holder device that uses data from the AlignRT system (3D surface imager) to make small movements of a patient's head to stabilize it during radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Robotic Head Holder Stabilization During Radiation Therapy	The total percentage of time that a participant is positioned ≤ 0.5mm and ≤ 0.5deg within target during radiation therapy.	24 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Michelle Alonso-Basanta, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Actual): October 14, 2025
• Study Completion (Actual): October 14, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: UPCC 02323; 855442 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No