Augmented Reality for Biopsies

Recruiting at 1 trial location

Overseen By Emily Leibold, BSE

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Claustrophobia, MR-unsafe implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the safety and effectiveness of an augmented reality system (also known as AR System or Virtual Guidance System) for guiding needle procedures like biopsies using MRI images. It focuses on enhancing accuracy and potentially reducing stress for patients. The trial seeks young participants, ages 3 to 21, who require an image-guided needle procedure in interventional radiology. Researchers will monitor participants for any side effects for two weeks following their procedure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future medical 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 prior data suggests that this augmented reality system is safe for MRI-guided needle procedures?

Research has shown that using augmented reality for needle procedures appears safe for patients. One study found that an augmented reality system guided bone biopsies effectively, reducing the number of CT scans needed without increasing risks. Another study demonstrated that this technology can track and display the needle and tumor in 3D, enhancing doctors' accuracy without causing additional harm.

These studies suggest that augmented reality systems are well-tolerated. Patients in these studies did not experience serious problems related to the technology. Negative side effects were uncommon, indicating a favorable safety profile for the system so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about augmented reality for biopsies because it offers a cutting-edge way to guide needle procedures more precisely. Unlike traditional image-guided techniques that rely on 2D images from CT or ultrasound, this system overlays digital images onto a real-world view, providing a 3D perspective during the procedure. This enhanced visualization could lead to more accurate targeting of the biopsy area, potentially reducing the risk of complications and improving outcomes for patients. Additionally, the augmented reality system might make the procedure less stressful for both doctors and patients by simplifying the process and potentially reducing procedure time.

What evidence suggests that this augmented reality system is effective for MRI-guided needle procedures?

Research has shown that augmented reality can improve the accuracy of needle biopsies. One study demonstrated that a biopsy system guided by augmented reality achieved an average accuracy of about 2.94 mm. Another study found augmented reality to be more precise than standard ultrasound for guiding needle biopsies. In animal tests, the augmented reality system consistently hit the target, maintaining only a tiny average distance from it. In this trial, participants will undergo their standard of care image-guided needle biopsy, aspiration, or injection using the Augmented Reality system. These findings suggest that augmented reality could enhance the precision and effectiveness of needle procedures. ^{5 6 7 8 9}

Who Is on the Research Team?

Karun Sharma, MD, PhD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality System

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

The augmented reality (AR) system combined with a 1.5-T closed-bore MRI for needle biopsies demonstrated high accuracy, with a mean localization error of just 1.1 mm for virtual targets and successful punctures in all animal trials.

The average procedure time for AR-guided biopsies was 18 minutes, indicating that this method is not only feasible but also efficient for performing biopsies in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An augmented reality system for MR image-guided needle biopsy: initial results in a swine model. Wacker, FK., Vogt, S., Khamene, A., et al.[2007]

An Augmented Reality (AR) image guidance system for spinal needle biopsies can effectively prevent damage to vital organs and ensure accurate targeting of lesions, enhancing the safety of the procedure.

The low-cost AR training setup uses a simple single-camera tracking system to provide real-time guidance for needle insertion, making it an accessible tool for training surgeons without the need for complex technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low cost augmented reality for training of MRI-guided needle biopsy of the spine. George, S., Kesavadas, T.[2008]

Augmented reality (AR) can effectively overlay 3D MRI scans onto live images during neurosurgery, with successful coregistration achieved in 7 out of 8 patients, demonstrating its potential for surgical planning and guidance.

This method is cost-effective, utilizing freeware software and standard digital cameras, but has limitations in deep-seated lesions and lacks continuous tracking, which may affect its reliability in certain surgical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel, inexpensive method of image coregistration for applications in image-guided surgery using augmented reality. Lovo, EE., Quintana, JC., Puebla, MC., et al.[2019]

In a randomized controlled trial involving 50 core biopsies of breast phantoms, biopsies guided by a 3D Augmented Reality (AR) system showed significantly greater accuracy compared to standard ultrasound-guided methods, with a mean deviation of 1.62 mm versus 2.48 mm (p<0.02).

The study indicates that AR guidance can enhance the precision of needle biopsies, potentially leading to better clinical outcomes in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms. Rosenthal, M., State, A., Lee, J., et al.[2022]

A new laboratory validation system has been developed to accurately measure operator performance in needle placement procedures, which is crucial for improving augmented reality (AR) systems used in medical imaging.

Preliminary studies using this system have begun to compare different assistance techniques, such as AR guidance and traditional methods, to assess their accuracy and effectiveness in guiding needle placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation system of MR image overlay and other needle insertion techniques. Fischer, GS., Dyer, E., Csoma, C., et al.[2007]

The augmented reality navigation system used in percutaneous CT-guided lung biopsies achieved a high diagnostic success rate of 96%, compared to 90% with traditional methods, indicating its effectiveness in clinical use.

This system significantly reduced procedure time and radiation exposure, with a notable decrease in the number of CT scans needed, while maintaining a similar complication rate (14% for augmented reality vs. 17% for traditional methods).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous computed tomography-guided lung biopsies: preliminary results using an augmented reality navigation system. Grasso, RF., Luppi, G., Cazzato, RL., et al.[2022]

The augmented reality (AR) navigation system for bone biopsies demonstrated safety and feasibility, with 100% technical success and efficacy in reaching the target and obtaining adequate specimens for all patients.

Compared to standard CT-guided biopsies, the AR system significantly reduced the number of CT passes and radiation exposure while maintaining similar procedure duration, indicating its potential to enhance patient safety during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone biopsies guided by augmented reality: a pilot study. Albano, D., Messina, C., Gitto, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11069180/

An augmented reality-guided biopsy system using a high- ... Our AR-guided biopsy system yielded an average targeting accuracy of 2.94 ± 1.04 mm and can be applied for real-time guidance of prostate biopsy as well as ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1361841502000889

Augmented reality guidance for needle biopsies 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07046832

Study Details | NCT07046832 | Clinical Evaluation of an ... The trial evaluates a novel augmented reality needle guidance platform that includes investigational software features and procedural performance data.

4. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2382041441

An Augmented Reality System for MR Image–guided ... In the animal experiments, the puncture was successful in all 10 cases, with a mean target-needle distance of 9.6 mm ± 4.85. The average ...

5. link.springer.com link.springer.com/article/10.1007/s10055-025-01184-3

the key to AR-navigated ultrasound-guided biopsy This research investigates how various factors influence the performance of AR navigation in ultrasound-guided biopsy, aiming to identify crucial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7806065/

Augmented Reality Guided Needle Biopsy of Soft Tissue This system is designed to track and visualize the needle and tumor in three-dimensional space using an electromagnetic tracking system.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10356701/

Bone biopsies guided by augmented reality: a pilot study This AR navigation system is safe, feasible, and effective; it can decrease radiation exposure and number of CT passes during bone biopsies without increasing ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05732558

Augmented Reality Navigation System (Endosight) for the ... The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010482524005377

Navigate biopsy with ultrasound under augmented reality ... This paper introduces an AR-based ultrasound biopsy navigation system characterized by high navigation accuracy and minimal latency.