Electromagnetic Device Tracking in Patients Undergoing CT-Guided Biopsy or Ablation - Full Text View

Purpose

RATIONALE: Electromagnetic device tracking may help in planning diagnostic procedures and cancer treatment.

PURPOSE: This clinical trial is studying electromagnetic device tracking to see how well it works in patients undergoing CT-guided biopsy or ablation.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific	Procedure: ablation Procedure: biopsy Procedure: computed tomography Procedure: electromagnetic tracking device procedure

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Virtual (tracked) to actual imaged device tip error [ Designated as safety issue: No ]
Root mean square (RMS) registration error [ Designated as safety issue: No ]
Distance between the device tip and any given fiducial marker on both virtual (tracked) and actual imaging [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2005
Estimated Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine the feasibility, accuracy, and registration error of electromagnetic device tracking in patients undergoing CT-guided biopsy or ablation.

OUTLINE: Three to 6 multimodality adhesive fiducial markers (about 1 cm in diameter) are placed on the skin near the region of interest. Patients then undergo planning contrast-enhanced CT scan. The images are transferred to a computer and matched to the patient's body location by clicking on the fiducial marker on the image while simultaneously placing the electromagnetic tracking device on the actual selected fiducial marker on the patient's body. Patients then undergo CT-guided biopsy or ablation using a needle that contains the electromagnetic tracking device. Spatial data, registration errors, and navigation errors of the electromagnetic tracking device are recorded.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Actively enrolled on an NIH clinical trial AND is scheduled to undergo CT-guided biopsy or ablation of a lesion

PATIENT CHARACTERISTICS:

Not pregnant
Negative pregnancy test
Able to hold breath (if procedure will be performed with conscious sedation and without general anesthesia)
Able to hold reasonably still on a procedure table for the length of the procedure
Gross body weight must not be above the CT scan table limit (375 pounds)
No known allergy to adhesives or latex
No skin reactions to dressings
No pacemakers or automatic implantable cardiac defibrillators
No uncorrectable coagulopathies
No multiple comorbid illnesses, sepsis, or multiple high-risk medical problems
No concurrent serious medical illness or altered mental status that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671840

Locations


United States, Maryland
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
	Bethesda, Maryland, United States, 20892-1182
	Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Bradford Wood, MD	National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000594244, NCI-05-CC-0091
First Received:	May 2, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00671840
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00671840