Augmented Reality for Biopsies

Recruiting in Palo Alto (17 mi)

Overseen by Karun Sharma, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's National Research Institute

Disqualifiers: Claustrophobia, MR-unsafe implants, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Augmented Reality System for biopsies?

Research shows that using an augmented reality system for guiding needle biopsies can improve accuracy. In a study comparing standard ultrasound guidance to augmented reality guidance, the augmented reality method resulted in a smaller average deviation from the target, suggesting it may help doctors perform more precise biopsies. ^{1 2 3 4 5}

How does the augmented reality treatment for biopsies differ from other treatments?

This treatment uses augmented reality (AR) to guide biopsies, providing a real-time overlay of virtual images onto the patient's body to help doctors see internal structures without invasive procedures. This approach is unique because it enhances precision and safety by allowing doctors to visualize the exact location for needle insertion, reducing the risk of damaging nearby organs. ^{1 3 4 6 7}

Eligibility Criteria

This trial is for patients who need MRI-guided needle procedures, such as biopsies or treatments for infections and pain. The study aims to test if using an augmented reality system can help with these procedures.

Inclusion Criteria

I am referred for a procedure using imaging to guide needle use.

I am between 3 and 21 years old.

Provision of signed and dated informed consent form

Exclusion Criteria

I weigh over 300 pounds.

I cannot give consent for the trial myself or through my parents.

I am under 3 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system

1 day

Follow-up

Participants are monitored for adverse events following their procedure

2 weeks

Treatment Details

Interventions

• Augmented Reality System (Procedure)

Trial Overview The intervention being studied is an augmented reality system designed to assist during MRI-guided needle interventions. The trial will assess the feasibility and safety of this technology in a clinical setting.

Participant Groups

Group I: Patients Undergoing Augmented Reality Image-Guided Needle Procedures Experimental Treatment 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's National Hospital Washington, United States

Who Is Running the Clinical Trial?

Children's National Research Institute Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Bone biopsies guided by augmented reality: a pilot study. [2023] To test the technical feasibility of an augmented reality (AR) navigation system to guide bone biopsies.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms. [2022] We report the results of a randomized, controlled trial to compare the accuracy of standard ultrasound-guided needle biopsy to biopsies performed using a 3D Augmented Reality (AR) guidance system. A board-certified radiologist conducted 50 core biopsies of breast phantoms, with biopsies randomly assigned to one of the methods in blocks of five biopsies each. The raw ultrasound data from each biopsy was recorded. Another board-certified radiologist, blinded to the actual biopsy guidance mechanism, evaluated the ultrasound recordings and determined the distance of the biopsy from the ideal position. A repeated measures analysis of variance indicated that the head-mounted display method led to a statistically significantly smaller mean deviation from the desired target than did the standard display method (2.48 mm for control versus 1.62 mm for augmented reality, p

3. United States pubmed.ncbi.nlm.nih.gov

Percutaneous computed tomography-guided lung biopsies: preliminary results using an augmented reality navigation system. [2022] "Augmented reality" is a technique to create a composite view by augmenting the real intervention field, visualized by the doctor, with additional information coming from a virtual volume generated using computed tomography (CT), magnetic resonance or ultrasound images previously acquired from the same patient. In the present study we verified the accuracy and validated the clinical use of an augmented reality navigation system produced to perform percutaneous CT-guided lung biopsies.

4. United States pubmed.ncbi.nlm.nih.gov

An augmented reality system for MR image-guided needle biopsy: initial results in a swine model. [2007] To evaluate an augmented reality (AR) system in combination with a 1.5-T closed-bore magnetic resonance (MR) imager as a navigation tool for needle biopsies.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Validation system of MR image overlay and other needle insertion techniques. [2007] In order to develop accurate and effective augmented reality (AR) systems used in MR and CT guided needle placement procedures, a comparative validation environment is necessary. Clinical equipment is prohibitively expensive and often inadequate for precise measurement. Therefore, we have developed a laboratory validation system for measuring operator performance using different assistance techniques. Electromagnetically tracked needles are registered with the preoperative plan to measure placement accuracy and the insertion path. The validation system provides an independent measure of accuracy that can be applied to varying methods of assistance ranging from augmented reality guidance methods to tracked navigation systems and autonomous robots. In preliminary studies, this validation system is used to evaluate the performance of the image overlay, bi-plane laser guide, and traditional freehand techniques.

6. United States pubmed.ncbi.nlm.nih.gov

A novel, inexpensive method of image coregistration for applications in image-guided surgery using augmented reality. [2019] Augmented reality (AR) is a technique in which an overlay of a virtual image to a live picture is performed to create a new image in which both original images coexist as a single image. This results in the visualization of internal structures through overlying tissues. The objective was to describe an easy, inexpensive, and successful method to coregister with AR in an image-guided surgery setting using the resources at hand.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Low cost augmented reality for training of MRI-guided needle biopsy of the spine. [2008] In needle biopsy of the spine, an Augmented Reality (AR) image guidance system can be very effective in ensuring that while targeting the lesion with the biopsy needle, vital organs near the spine are not damaged and that the approach path is accurate. This procedure requires skill that is hard to master on patients. In this paper, we present a low cost AR based training set-up which consists of a software that uses one static single-camera tracking mechanism to locate the biopsy needle in the patient and which then augments the camera feed of the patient with virtual data providing real-time guidance to the surgeon for insertion of the biopsy needle. The setup is implemented using a phantom model consisting of a set of carefully modeled holes to simulate the needle insertion task. The lack of requirement of elaborate infrared tracking systems and high computing power makes this system very effective for educational and training purposes.