NCT06776406

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

September 4, 2024

Last Update Submit

November 20, 2025

Conditions

Brain Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Head Stabilization

EXPERIMENTAL

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

Interventions

Freedom Pursuit Robotic PlatformDEVICE

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.

Head Stabilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michelle Alonso-Basanta, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 4, 2024

First Posted

January 15, 2025

Study Start

October 14, 2025

Primary Completion

October 14, 2025

Study Completion

October 14, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)