Augmented Reality For MRI-Guided Interventions

Augmented Reality Real-Time Guidance 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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Pain; Diagnosis; Image Guided Needle Biopsy
• Intervention / Treatment: Device: Augmented Reality System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Leibold, BSE; Phone Number: 202-476-5522; Email: eleibold@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Contact: Karun Sharma, MD, PhD; Phone Number: 202-476-3791; Email: kvsharma@childrensnational.org
      • Contact: Emily Leibold, BSE; Phone Number: 202-476-5522; Email: eleibold@childrensnational.org
      • Principal Investigator: Karun Sharma, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients Undergoing Augmented Reality Image-Guided Needle Procedures; Patients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.	Device: Augmented Reality System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Total procedure time.	1 day
Number of MRI scans	Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.	1 day
Clinical impressions of the system use and utility	The operator will complete a usability form that captures ease of use using the Likert scale.	1 Day

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Investigators: Principal Investigator: Karun Sharma, MD, PhD, Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000648

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No