Brain CancerNCT06776406
Head Stabilization in Whole Brain RT
A study testing Freedom Pursuit Robotic Platform in people with Brain Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Freedom Pursuit Robotic Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 and older undergoing whole brain radiation therapy
- Participants must sign the informed consent form
Who cannot join
- All patients not meeting the above inclusion criteria will not be considered for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Cancer
- Being tested
- Freedom Pursuit Robotic Platform
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Freedom Pursuit Robotic Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start14 Oct 2025
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Why it stopped: Grant ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Alonso-Basanta, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776406
- Sponsor's protocol ID
- UPCC 02323
- Other IDs
- 855442
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Head Stabilization of Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT06776406
- Acronym / sponsor ID
- UPCC 02323
- Conditions
- Brain Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head Stabilization | Experimental | Device: Freedom Pursuit Robotic PlatformReal-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 and older undergoing whole brain radiation therapy
- Participants must sign the informed consent form
Key exclusion criteria (1 listed)
- All patients not meeting the above inclusion criteria will not be considered for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freedom Pursuit Robotic PlatformThe 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. | Device | Head Stabilization |
Primary outcome
Robotic Head Holder Stabilization During Radiation Therapy
Time frame: 24 months
The total percentage of time that a participant is positioned ≤ 0.5mm and ≤ 0.5deg within target during radiation therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Alonso-Basanta, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Pursuit Robotic Platform in people with Brain Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Robotic Head Holder Stabilization During Radiation Therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.