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Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

This study is currently recruiting participants.
Verified June 19, 2017 by National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
First Posted: January 31, 2005
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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.

Adenocarcinoma Prostate Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electromagnetic Tracking of Devices During Interventional Procedures

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To define the clinical utility of electromagnetic tracking during surgery and interventional procedures in specific patient populations [ Time Frame: Completion of study ]

Estimated Enrollment: 3195
Study Start Date: January 27, 2005
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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.
  Contacts and Locations
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

Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov
Contact: Bradford Wood, M.D. (301) 496-7739 bwood@mail.cc.nih.gov

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00102544     History of Changes
Obsolete Identifiers: NCT00671840
Other Study ID Numbers: 050091
First Submitted: January 29, 2005
First Posted: January 31, 2005
Last Update Posted: October 19, 2017
Last Verified: June 19, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Electromagnetic Tracking
Ultrasound-Guided Biopsy
Surgical Navigation

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases