Augmented Reality for Biopsies

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

12 Participants Needed

Trial Summary

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}

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.

Research Team

Karun Sharma, MD, PhD

Principal Investigator

Children's National Research Institute

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.

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

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Findings from Research

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]

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]

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) 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]

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]

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]

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]

References

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

Bone biopsies guided by augmented reality: a pilot study. [2023]

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

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms. [2022]

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

Percutaneous computed tomography-guided lung biopsies: preliminary results using an augmented reality navigation system. [2022]

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]

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

Validation system of MR image overlay and other needle insertion techniques. [2007]

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]

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

Low cost augmented reality for training of MRI-guided needle biopsy of the spine. [2008]