An interventional study of EM Tracking in Adenocarcinoma, Prostate Neoplasms and Prostate Cancer, sponsored by National Institutes of Health Clinical Center (CC). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Device feasibility
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:
Background:
The effectiveness of targeting lesions or a specific area for surgery, angiography, CT-guided, or ultrasound-guided biopsy, or ablation, currently may be limited by the visibility of a target during the procedure. Accurate therapeutic intervention may depend upon accurate device placement, which may be very difficult in certain settings, such as when a liver tumor only is visible for a brief moment in time during the transient arterial phase of a contrast injection, soon disappearing on dynamic imaging. Surgery, angiography, image guided therapies and diagnostic procedures could be vastly improved by enabling the use of pre-procedural imaging during the procedure [such as location of difficult to visualize or transiently visible targets].Tracking devices allow the use of preoperative imaging during the procedure. Having this information available could vastly improve targeting accuracy of surgery, angiography, CT-guided, or ultrasound-guided biopsy or ablation.
A method of improving targeting could potentially benefit patients in the future by reducing total radiation exposure during CT scan or fluoroscopic monitoring of a biopsy, or decreasing certain surgical risks, although these are not specific subjects of this study. Various methods of device tracking have been used in the past throughout the 20th and 21st century in neurosurgery with the use of stereotactic frames for a similar purpose, to register pre-operative imaging to the patient during invasive procedures to guide treatment.
Objectives:
To define the clinical utility of electromagnetic tracking during interventional procedures in specific patient populations.
Eligibility:
Design:
This is an exploratory interventional study examining the use of a guidance system for navigating and monitoring devices like biopsy and ablation needles, ultrasound transducers, needle guides, guidewires, scalpels, and cauterization devices (herein referred to as device(s) ) for localization in relation to pre-operative images. There are 9 cohorts included in this protocol: The Open / Laparoscopic surgery and Angiography surgery cohorts are no longer open for accrual.
The total accrual ceiling for this protocol is 3894 subjects.
All cohorts open for accrual are using exploratory interventions to define the specific patient population where fusion used during interventional procedures may have clinical value, and to characterize that clinical value in a specific patient population, such as but not limited to patients with specific regions of the prostate targeted, specific prostate volumes, prior negative prostate biopsies, or PSA values within a specific range.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 3,894 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must fulfill all of the following criteria to be eligible for study admission. Patient enrollment is by referral only.
PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA:
1. Patients are eligible if they have undergone a prostate MRI and have had abnormalities identified as follows:
EXCLUSION CRITERIA:
Patients with any of the following will be excluded from study entry:
This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .
Device: EM Tracking
Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.
Feasibility of using electromagnetic devices in different cohorts.
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
Time frame: Day 1
Success of ablation as determined by imaging
Primary effectiveness (success of ablation in local tumor control or success of biopsy in diagnostic biopsy sample). Successful ablation equals complete tumor ablation with a 5mm-1cm margin of normal tissue (if possible; quantified by the lack of enhancement of intravenous contrast material at 3 month follow up CT)
Time frame: 3 months
Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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National Institutes of Health Clinical Center (CC)