EM Tracking Devices for Biopsy Accuracy in Kidney and Prostate Cancer

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Altered mental status, Pacemakers, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tracking device, EM Tracking, designed to improve the accuracy of biopsies and ablations for hard-to-see tumors, such as those in the kidney and prostate. The device functions like a mini GPS, helping doctors precisely locate lesions that standard imaging methods often miss. Participants must have a lesion requiring a biopsy or ablation typically guided by CT. The trial uses a special needle with a tiny magnet to ensure accurate placement, potentially leading to better outcomes in future procedures. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future medical procedures.

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 prior data suggests that this tracking device is safe for biopsy procedures?

Research has shown that EM tracking devices, used in procedures like biopsies, are generally easy for patients to handle. Studies have found that these devices help doctors place needles more accurately. They use a weak magnet to guide the needle, similar to a mini GPS. This can speed up the procedure and might even reduce radiation exposure.

Although researchers are still testing these tracking devices, studies have not identified any major safety problems. Participants in similar studies did not report any serious side effects from using these devices. Overall, research indicates that using EM tracking in procedures is both safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EM Tracking devices for kidney and prostate cancer biopsies because these devices offer real-time precision during procedures. Unlike traditional methods that rely on static imaging, EM Tracking provides dynamic, near-simultaneous imaging updates, enhancing biopsy accuracy. This technology could lead to more precise targeting of cancerous tissues, potentially improving diagnostic outcomes and reducing the need for repeat procedures.

What evidence suggests that this tracking device is effective for improving biopsy accuracy in kidney and prostate cancer?

Research has shown that electromagnetic (EM) tracking devices can improve needle placement accuracy during biopsies. In this trial, participants will undergo procedures using EM tracking to enhance biopsy precision. One study found that this technology detected cancer in 39% of cases on a second biopsy attempt. This "smart needle" functions like a GPS, using a weak magnet to guide it to the correct location. Early results suggest that, when combined with other imaging methods, it can increase cancer detection rates by up to 15%. This accuracy could be particularly useful for identifying hard-to-see tumors in the kidney or prostate. ^{1 6 7 8 9}

Who Is on the Research Team?

Peter A Pinto, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

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

No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation

Exclusion Criteria

Gross body weight above the CT table limit (606 pounds), if CT table used

Patients with pacemakers and other potentially electrically conductive implants

I can't stay still for long periods on a procedure table.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: All cohorts (prostate biopsy percutaneous biopsy and ablation) Experimental Treatment 1 Intervention

This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma. Amalou, H., Wood, BJ.[2021]

Citations

1. withpower.com withpower.com/trial/phase-3-carcinoma-renal-cell-1-2005-6a937

EM Tracking Devices for Biopsy Accuracy in Kidney and ... This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4254112/

Initial Experience with Electronic Tracking of Specific ... At initial biopsy, 23 cancers were within an MRI target, and 51 were found on systematic biopsy. Cancer detection rate on repeat biopsy (29/74, 39%) was ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814021090228

Performance of an integrated multimodality image ... Multimodal image registration and electromagnetic (EM) tracking are two technologies integrated into a prototype system in the early phase of clinical ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1910038

MRI-Targeted, Systematic, and Combined Biopsy for ... Cancer detection rates on MRI-targeted biopsy were significantly lower than on systematic biopsy for grade group 1 cancers and significantly ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554556/

Advances in imaging and artificial intelligence for precision ... In recent years, multimodal image fusion technology has boosted the detection rate of csPCa by 10%-15% via precise lesion localization.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10887197/

Safety and Diagnostic Efficacy of Image-Guided Biopsy ... This study investigates the safety and effectiveness of using image-guided biopsy to diagnose small renal masses less than 4 cm in size.

7. ajronline.org ajronline.org/doi/10.2214/AJR.10.5151

Electromagnetic Navigation System for CT-Guided Biopsy of ... Virtual electro mag netic tracking appears to have high accuracy in needle placement, potentially reducing time and radiation exposure.

8. clinicaltrial.be clinicaltrial.be/en/details/177827?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Use of Tracking Devices to Locate Abnormalities During In... Tracking devices allow the use of preoperative imaging during the procedure. Having this information available could vastly improve targeting ...

9. nature.com nature.com/articles/s44172-024-00254-9

Automatic renal carcinoma biopsy guidance using forward- ... Tumor demonstrated high recognition performance, with 98.19% accuracy, 91.85% precision, 99.83% recall, and 95.67% F1 score. However, normal ...