Use of Tracking Devices to Locate Abnormalities During Invasive Procedures - Full Text View

Sponsored by:	National Institutes of Health Clinical Center (CC)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00102544

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:

Small 1-cm plastic donuts are place on the skin with tape.
A planning CT scan is done.
The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet.
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.
A repeat CT is done as it normally is to look for the location of the needle.
After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan.

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Condition
Tomography, Emission-Computed

MedlinePlus related topics: CT Scans Nuclear Scans Surgery

U.S. FDA Resources

Study Type:	Observational
Official Title:	Electromagnetic Tracking of Devices During Interventional Procedures: A Pilot Study

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

Estimated Enrollment:	540
Study Start Date:	January 2005

Detailed Description:

This study will examine 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.

Pre-procedural contrast enhanced CT scan, MRI, or PET scan will be aligned and matched to the patient and then to the spatial coordinates of a device.

We will use a commercial weak magnetic field generator combined with biocompatible devices. These devices have a very small sensor coil buried within the metal that can be localized within this magnetic field. The coil never touches the patient and cannot come off the devices. An insulated wire runs from the devices to the computer. Custom software will be used to analyze the signal sent by the devices to localize the devices within a pre-operative reference imaging set (contrast enhanced CT scan, MRI, or PET scan). The software will be the same that we have used extensively in phantoms, in animals, and humans, and displays a graphical user interface that shows the device location within the pre-operative imaging data set. Similar systems have been routinely used in neurosurgery and otolaryngology for many years for similar purposes, but these tracking systems have not been widely applied to abdominal surgery, angiograpy, or CT or ultrasound-guided procedures to date. Such navigation systems have traditionally relied upon infrared or optical signals for localization, instead of electromagnetics. Such systems could dramatically improve the way that devices are tracked while inside the body, and allow direct use of pre-operative images, instead of relying upon the operator's spatial awareness and mental model building.

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:

All patients must have a pre-operative CT, MR, or PET scan performed at NIH and be undergoing surgery or an interventional procedure.
Age greater than 18 years.
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
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.
Ability to hold breath (if procedure to be performed with conscious sedation, and without general anesthesia).
Non-prostate biopsy patients must be actively enrolled on an NIH protocol and be scheduled for surgery, angiography, or CT- or ultrasound-guided biopsy.

PROSTATE BIOPSY COHORT INCLUSION CRITERIA:
All patients in the Prostate Biopsy Cohort will be followed by NCI urologic oncology service.
PSA greater than 2.5 or Abnormal digital rectal exam
Pre-biopsy prostate MRI with endorectal coil and showing targetable lesions.

EXCLUSION CRITERIA:

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

Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
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).
Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
Patients with pacemakers or automatic implantable cardiac defibrillators.
Gross body weight above the CT table limit (375 pounds).
Pregnancy.
Patients with uncorrectable coagulopathies.

Contacts and Locations

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

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Seiler PG, Blattmann H, Kirsch S, Muench RK, Schilling C. A novel tracking technique for the continuous precise measurement of tumour positions in conformal radiotherapy. Phys Med Biol. 2000 Sep;45(9):N103-10.

Frantz DD, Wiles AD, Leis SE, Kirsch SR. Accuracy assessment protocols for electromagnetic tracking systems. Phys Med Biol. 2003 Jul 21;48(14):2241-51.

Solomon SB, White P Jr, Wiener CM, Orens JB, Wang KP. Three-dimensional CT-guided bronchoscopy with a real-time electromagnetic position sensor: a comparison of two image registration methods. Chest. 2000 Dec;118(6):1783-7.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Krucker J, Xu S, Glossop N, Viswanathan A, Borgert J, Schulz H, Wood BJ. Electromagnetic tracking for thermal ablation and biopsy guidance: clinical evaluation of spatial accuracy. J Vasc Interv Radiol. 2007 Sep;18(9):1141-50.

Study ID Numbers:	050091, 05-CC-0091
Study First Received:	January 29, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00102544 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Magnetic Tracking
Surgical Navigation
Image-guided Therapy
Surgical Navigation

Study placed in the following topic categories:

Congenital Abnormalities

ClinicalTrials.gov processed this record on May 07, 2009