Augmented Reality For MRI-Guided Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented Reality System.
- Who it may be relevant to
- Registry conditions: Infections, Pain, Diagnosis. Basic parameters: 3 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
Overview
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.
Interventions
- 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.
Primary outcome measures
- Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system. [Time frame: 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. [Time frame: 7 days]
Secondary outcome measures (3)
- Procedure time [Time frame: 1 day]
- Number of MRI scans [Time frame: 1 day]
- Clinical impressions of the system use and utility [Time frame: 1 Day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Identifiers
NCT: NCT06224933 · STUDY00000648