Augmented Reality Guided Biopsy for Cancer

Enrolling by invitation at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MediView XR, Inc.

Disqualifiers: Children, Pregnant, Pacemakers, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to guide biopsies, which involve taking a small tissue sample to check for cancer. It employs augmented reality, a technology that overlays digital information on the real world, to assist doctors during the biopsy. Participants are divided into two groups: one using this new technology and another using standard methods like CT scans and ultrasounds. Suitable candidates for this trial are adults needing a soft-tissue biopsy, particularly those with lesions between 1 and 8 centimeters deep. As an unphased trial, this study provides patients the chance to experience cutting-edge technology that could enhance biopsy accuracy and outcomes.

Do I need to stop my current medications for the trial?

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

What prior data suggests that the XR90 Augmented Reality imaging and guidance platform is safe for percutaneous soft tissue biopsy?

Research shows that the XR90 augmented reality (AR) guidance system is safe and effective for procedures like biopsies. Studies have found that it reduces radiation exposure and decreases the number of CT scans needed during bone biopsies, without increasing side effects. Patients generally tolerate the system well.

Tests in both lab and real-world settings have confirmed its safety and effectiveness. While this trial aims to explore these benefits further, previous research offers a reassuring background for considering the XR90 system a safe choice for guided biopsies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of augmented reality (AR) in guiding biopsies for cancer. Unlike standard biopsy procedures that rely solely on CT and ultrasound for needle guidance, the experimental approach uses the XR90 guidance system, which integrates augmented reality to enhance precision. This innovative method could potentially improve accuracy and reduce the risks associated with biopsies, making it a promising advancement in cancer diagnostics.

What evidence suggests that the XR90 Augmented Reality Guided Biopsy is effective for cancer?

This trial will compare augmented reality (AR) in biopsy procedures with standard care methods. Research has shown that AR can enhance the accuracy of biopsy procedures. Studies have found that AR systems help doctors target the right tissues, reducing mistakes. One AR system demonstrated high precision and speed, making the procedure smoother. These systems also allow doctors to see a 3D image of the needle and tumor, ensuring precise needle insertion. Overall, AR technology in biopsies appears promising for increasing precision and safety. Participants in this trial may be assigned to the experimental group using the XR90 AR guidance system or to the standard care group using traditional CT and ultrasound guidance. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who require a biopsy of soft tissue due to conditions like liver or kidney cancer. Participants should be suitable candidates for ultrasound-guided biopsies and willing to try an augmented reality guidance system.

Inclusion Criteria

I am eligible for a needle biopsy guided by ultrasound.

I am 18 years old or older.

Willing and able to give informed consent prior to enrollment

Exclusion Criteria

Not willing or able to give informed consent

Subjects with pacemakers or AICDs

Currently pregnant at the time of the procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraprocedural

Participants undergo percutaneous biopsy procedures using either standard of care guidance or the XR90 guidance system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality Guided Biopsy

Trial Overview The study tests the XR90 Augmented Reality imaging and guidance platform against standard ultrasound-guided biopsy techniques in patients undergoing soft tissue biopsies, aiming to assess safety and procedural benefits.

How Is the Trial Designed?

Group I: Arm A, XR90 (Experimental Group) Experimental Treatment 1 Intervention

Participants randomly assigned to this arm will undergo percutaneous biopsy procedures using the assistance of XR90 guidance system in adjunct to standard of care guidance.

Group II: Arm B (Standard of Care Group) Active Control 1 Intervention

Participants randomly assigned to this arm will undergo percutaneous biopsy with standard of care CT and ultrasound needle guidance only.

Who Is Running the Clinical Trial?

MediView XR, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07120906

Augmented Reality Real-Time Guidance for MRI-Guided ... The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL ...

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

An augmented reality-guided biopsy system using a high- ... In this study, we developed an augmented reality (AR) system to improve biopsy procedures and increase targeting accuracy. Our AR-guided biopsy system uses a ...

3. 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.

4. withpower.com withpower.com/trial/phase-interventional-radiology-5-2025-c5d48

Augmented Reality Guided Biopsy for Cancer This trial is for individuals who require a biopsy of soft tissue due to conditions like liver or kidney cancer. Participants should be suitable candidates for ...

5. frontiersin.org frontiersin.org/journals/robotics-and-ai/articles/10.3389/frobt.2020.00072/full

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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07046832

Clinical Evaluation of an Augmented Reality ... This multicenter prospective randomized control trial is designed to compare the efficacy and utility of the XR90 guidance platform used adjunct to standard of ...

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 ...