Actively Recruiting
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
Led by Children's National Research Institute · Updated on 2025-09-05
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of an augmented reality (AR) system to assist patients undergoing MRI-guided needle procedures such as biopsies, aspirations, or injections. This pilot clinical study aims to determine if the AR system can be successfully used during these procedures without changing the standard care or procedural techniques. The study is sponsored by the Children's National Research Institute and includes patients ages 3 to 21. Participants will receive their usual MRI-guided needle procedure while the interventional radiologist uses the AR system to better visualize the needle entry point and path toward the target. This device provides a real-time AR display to potentially improve needle placement accuracy and reduce procedure time. After the procedure, patients will be monitored for adverse events for two weeks. During the study, researchers will assess how often the AR system can be successfully used, procedure-related adverse events within 7 days, procedure time, the number of MRI scans performed, and clinical impressions of the system's usefulness. Participants will be evaluated closely with these measures shortly after the procedure. The total participation duration includes the procedure day and a two-week follow-up period to ensure safety and feasibility.
CONDITIONS
Brief Title
Augmented Reality For MRI-Guided Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female, ages 3 to 21
- Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy
You will not qualify if you...
- Unable to give informed consent themselves or through a parent/guardian
- Under 3 years of age
- Weighs over 300 pounds
- Claustrophobic and unable to tolerate MRI-guided procedure
- Has contraindications to MRI such as MR-unsafe implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 1 day
Participants undergo their standard image-guided needle biopsy, aspiration, or injection procedure with guidance from the Augmented Reality system.
1 procedure visit (in-person)
Duration - 2 weeks
Participants are monitored for adverse events following their procedure.
1 to 2 follow-up visits depending on monitoring needs
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
E
Emily Leibold, BSE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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