Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00102544
First received: January 29, 2005
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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
Tomography, Emission-Computed

Study Type: Observational
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):

Estimated Enrollment: 3215
Study Start Date: January 2005
Detailed Description:

Background:

The effectiveness of targeting lesions 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 pre-operative 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 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 surgery and interventional procedures in specific patient populations

Eligibility:

  1. All patients must have a pre-operative CT, MR, or PET scan performed at NIH.
  2. Age greater than 18 years.
  3. Patients, except those undergoing RFA or prostate biopsy must be actively enrolled on an NIH protocol and be scheduled for surgery, angiography, or CT- or ultrasound-guided biopsy.

Design:

This is a pilot 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.

  1. Prostate biopsy
  2. Percutaneous biopsy for diagnostic correlation
  3. percutaneous ablation for needle placement compilations
  4. Open/Laparoscopic surgery
  5. Angiography 6) Auto registration for biopsy and

7) ablation 8) PET registration

9) prostate biopsy on which to determine the predictive value and relative strength of each MRI sequence in predicting cancer at a specific prostate core location.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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. Patients, except for those in enrolling in Cohorts 1 and 9, must be actively enrolled in an NIH protocol.
  6. For surgery cohort, patients must be undergoing a surgical procedure and have pre-operative imaging.

PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102544

Contacts
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

Locations
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
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00102544     History of Changes
Obsolete Identifiers: NCT00671840
Other Study ID Numbers: 050091, 05-CC-0091
Study First Received: January 29, 2005
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Tracking
Surgical Navigation
Image-guided Therapy

ClinicalTrials.gov processed this record on July 24, 2014