Head Stabilization in Whole Brain RT

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Head Stabilization in Whole Brain RT

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06776406
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abramson Cancer Center at Penn Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michelle Alonso-Basanta, MD, PhD
Principal Investigator Affiliation	University of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Cancer

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Project Manager

[email protected]

215-662-3790