3894 Participants Needed

EM Tracking Devices for Biopsy Accuracy in Kidney and Prostate Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Institutes of Health Clinical Center (CC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment EM Tracking for biopsy accuracy in kidney and prostate cancer?

Research shows that electromagnetic (EM) tracking can improve the accuracy of biopsies by allowing real-time visualization of needle positions and better defining tumor targets, as demonstrated in procedures for liver and kidney tumors.12345

Is EM Tracking safe for use in humans?

A study comparing electromagnetic needle tracking (EMT) with freehand ultrasound-guided liver biopsies suggests that EMT is a safe method for guiding biopsies, as it was evaluated for liver procedures without reported safety concerns.12567

How does the EM tracking device treatment for biopsy accuracy in kidney and prostate cancer differ from other treatments?

The EM tracking device treatment is unique because it uses electromagnetic navigation to improve the accuracy of biopsies, which helps in precisely targeting small lesions. This method is different from traditional freehand techniques as it combines image fusion technology to guide the biopsy needle more accurately.23689

What is the purpose of this trial?

This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, such as biopsy or ablation, that cannot easily be visualized by usual imaging techniques, such as computed tomography (CT) scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine abnormalities, and others, may be hard to find or only visible for a few seconds. The new method uses a needle with a miniature tracking device buried inside the metal that tells where the tip of the needle is located, somewhat like a mini GPS, or global positioning system. It uses a very weak magnet to localize the device like a miniature satellite system. This study will explore whether this system can be used in the future to more accurately place the needle in or near the desired location or abnormality.Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation procedure that requires CT guidance may be eligible for this study. Candidates are screened with a medical history and review of medical records, including imaging studies.Participants undergo the biopsy or ablation procedure as they normally would, with the following exceptions: some stickers are placed on the skin before the procedure and a very weak magnet is placed nearby. The needles used are similar to the ones that would normally be used except that they contain a metal coil or spring buried deep within the needle metal. The procedure involves the following steps:1. Small 1-cm plastic donuts are place on the skin with tape.2. A planning CT scan is done.3. The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet.4. The needle used for the procedure is placed towards the target tissue or abnormality and the "smart needle" location lights up on the old CT scan.5. A repeat CT is done as it normally is to look for the location of the needle.6. After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan....

Research Team

BJ

Bradford J Wood, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

Adults over 18 needing a biopsy or ablation guided by CT, with lesions hard to locate using standard imaging. They must understand and agree to the study's terms, be able to lie still during the procedure, and not have severe illnesses affecting decision-making. Excluded are those over 606 pounds, unable to hold their breath if needed, mentally unable to consent, or with pacemakers/electrical implants.

Inclusion Criteria

I have had a prostate MRI showing abnormalities and need a biopsy.
All patients must have a pre-operative imaging (CT, MR, or PET scan) available in digital format
The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained
See 2 more

Exclusion Criteria

Gross body weight above the CT table limit (606 pounds), if CT table used
I can't stay still for long periods on a procedure table.
Patients with pacemakers and other potentially electrically conductive implants
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo biopsy or ablation procedure with the experimental tracking device

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

3 months
1 visit (in-person) at 3 months

Treatment Details

Interventions

  • EM Tracking
Trial Overview The trial is testing an experimental 'smart needle' equipped with a tracking device for better accuracy in locating hard-to-find abnormalities during invasive procedures like biopsies. It works like mini GPS inside the body using weak magnets and aims to improve needle placement.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: All cohorts (prostate biopsy percutaneous biopsy and ablation)Experimental Treatment1 Intervention
This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials
391
Recruited
30,880,000+

Findings from Research

Electromagnetic (EM) tracking technology enhances image-guided procedures by allowing the use of multiple imaging modalities, which is particularly beneficial for patients with renal insufficiency who need to avoid nephrotoxic iodinated contrast.
In a successful case, EM tracking was utilized to ablate a poorly visualized renal tumor by integrating CT, gadolinium-enhanced MRI, and contrast-enhanced ultrasound, improving tumor localization and targeting during the procedure.
Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma.Amalou, H., Wood, BJ.[2021]

References

The role of 3-dimensional mapping biopsy in decision making for treatment of apparent early stage prostate cancer. [2022]
Prospective comparison of freehand and electromagnetic needle tracking for US-guided percutaneous liver biopsy. [2016]
Evaluation of an electromagnetic image-fusion navigation system for biopsy of small lesions: assessment of accuracy in an in vivo swine model. [2022]
Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma. [2021]
Should follow-up biopsies for men on active surveillance for prostate cancer be restricted to limited templates? [2013]
Can biopsy be a reliable predictor of spatial distribution of prostate cancer? Comparison of a novel biopsy regimen with radical prostatectomy findings. [2016]
Extended biopsy protocol decreases prostate cancer incidence and risk of aggressive disease on repeated biopsies compared with initial standard procedure. [2010]
Robot arm based flat panel CT-guided electromagnetic tracked spine interventions: phantom and animal model experiments. [2021]
Systematic Review and Meta-Analysis of Free-Hand and Fixed-Arm Spatial Tracking Methodologies in Software-Guided MRI-TRUS Fusion Prostate Biopsy Platforms. [2023]
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