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Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00102544
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2005
Last Update Posted : November 2, 2022
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Prostate Neoplasms Prostate Cancer Renal Cell Carcinoma Von Hippel Lindau Disease Device: EM Tracking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3245 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Electromagnetic Tracking of Devices During Interventional Procedures
Actual Study Start Date : February 23, 2005
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : January 2, 2024

Arm Intervention/treatment
Experimental: All cohorts (prostate biopsy percutaneous biopsy and ablation)
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.

Primary Outcome Measures :
  1. Feasibility of using electromagnetic devices in different cohorts. [ Time Frame: Day 1 ]
    "TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))

Secondary Outcome Measures :
  1. Success of ablation as determined by imaging [ Time Frame: 3 months ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patients must fulfill all of the following criteria to be eligible for study admission:

  1. All patients must have a CT, MR, or PET scan available in digital format.
  2. Age greater than or equal to 18 years.
  3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
  4. 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.
  5. All patients in non-prostate biopsy cohorts, must be undergoing a surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy and have pre-operative imaging.


1. Source of patients will be the community at large as well as patients who have undergone prostate MRI and have had abnormalities identified as follows:

  1. PSA >2.5 or Abnormal digital rectal exam or an abnormality identified on prostate MRI witha clinical indication for biopsy.
  2. Pre-biopsy prostate MRI showing targetable lesions.


Patients with any of the following will be excluded from study entry:

  1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
  2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
  3. Patients with any known allergy to adhesives or latex or skin reactions to dressings (since the adhesive fiducials could theoretically induce a rash in these patients), if adhesive fiducials are to be used.
  4. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
  5. Patients with pacemakers or automatic implantable cardiac defibrillators.
  6. Gross body weight above the CT table limit (375 pounds), if CT table used.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102544

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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
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Principal Investigator: Bradford J Wood, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00102544    
Obsolete Identifiers: NCT00671840
Other Study ID Numbers: 050091
First Posted: January 31, 2005    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: September 22, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .It is not yet known if there will be a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by National Institutes of Health Clinical Center (CC):
Electromagnetic Tracking
Ultrasound-Guided Biopsy
Surgical Navigation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Carcinoma, Renal Cell
Von Hippel-Lindau Disease
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neurocutaneous Syndromes
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn