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NCT Number: NCT06224933

Augmented Reality For MRI-Guided Interventions

The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.

Recruiting

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Key information

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location status: Recruiting

Location contact

Emily Leibold, BSE

CONTACT

[email protected]

202-476-5522

Karun Sharma, MD, PhD

CONTACT

[email protected]

202-476-3791

Karun Sharma, MD/PhD

PRINCIPAL_INVESTIGATOR

About this study

This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Augmented Reality System

Device

Subjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.

Primary outcomes

  1. Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.

    Time frame: 1 day

  2. 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.

    Time frame: 7 days

Secondary outcomes

  1. Procedure time

    Time frame: 1 day

    Total procedure time.

  2. Number of MRI scans

    Time frame: 1 day

    Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.

  3. Clinical impressions of the system use and utility

    Time frame: 1 Day

    The operator will complete a usability form that captures ease of use using the Likert scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Leibold, BSE

CONTACT

[email protected]

202-476-5522

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Augmented Reality Real-Time Guidance for MRI-Guided Interventions

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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