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Augmented Reality for MRI-Guided Procedures in Children and Young Adults

This study is testing a new Augmented Reality System to help doctors perform MRI-guided needle procedures like aspirations (removing fluid), injections, or biopsies (taking tissue samples). This system helps the doctor see the needle's path more clearly during the procedure. We want to see if this system is practical to use and safe for patients. You might be able to join if you are between 3 and 21 years old and have been referred for an image-guided needle procedure. The study aims to successfully complete over 80% of cases using the system and will track any side effects within 7 days. The current status of this study is unclear, and it plans to enroll 25 participants.

Study design
This is an interventional pilot study designed to evaluate a new device in up to 12 patients. It is not specified if it is randomized or blinded.
What's involved
You would undergo an image-guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. Adverse events will be assessed within 7 days of the procedure.
Compensation
Not stated in the trial record.
Follow-up
Safety will be evaluated for adverse events that occur within 7 days of the procedure.

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NCT06224933

Augmented Reality For MRI-Guided Interventions

Recruiting
NAAges 3–21InterventionalDevice feasibility
Children's National Research Institute
~25 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:Augmented Reality System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
Measured over 1 day
+1 more outcome measured

Conditions

Infections
Pain
Diagnosis

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InfectionMisdiagnosisPain

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Karun Sharma, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

Emily Leibold, BSE
[email protected]
202-476-5522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ages 3 to 21
Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.

Exclusion

Patients who are unable to give informed consent themselves or through their parents.
Patients under 3 years of age
Patients over 300 pounds.
Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
Contraindications to MRI such as MR-unsafe implants.

What this trial measures

  • Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.1 day
  • Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.7 days