Head Stabilization in Whole Brain RT

Not Applicable

Not yet recruiting

• Conditions: Brain Cancer

• Registration Number: NCT06776406
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Start: 2025-08
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States