Augmented Reality For MRI-Guided Interventions
Purpose
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
Conditions
- Infections
- Pain
- Diagnosis
- Image Guided Needle Biopsy
Eligibility
- Eligible Ages
- Between 3 Years and 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT06224933
- Status
- Recruiting
- Sponsor
- Children's National Research Institute
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.