Augmented Reality For MRI-Guided Interventions

Not Applicable

Recruiting

• Conditions: Infections; Pain; Image Guided Needle Biopsy; Diagnosis
• Interventions: Device: Augmented Reality System

• Registration Number: NCT06224933
• Lead Sponsor: Children's National Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-11-22
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Study Start: 2024-02-20
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Undergoing Augmented Reality Image-Guided Needle Procedures	Augmented Reality System	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States