Electromagnetic Tracking of Devices During Interventional Procedures - Full Text View

Purpose

This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.

Condition
Biopsy or Ablation Procedures

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

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:

Target Registration Error [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))

Secondary Outcome Measures:

Success of ablation as determined by imaging [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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).

Estimated Enrollment:	300
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Biopsy/Ablation - CONTROL GROUP The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded by pushing the start button again.
Biopsy/Ablation - STUDY GROUP: The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. The physician will then be un-blinded and shown the PercuNav screen and will correct the desired approach path and another screen capture will be taken. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded. At the end of the procedure, and if clinically indicated, a verification "CT" computed tomography scan will be taken with the needle in place and, sent to the PercuNav. Radiation dosage, due to CT imaging, will also be recorded.

Groups/Cohorts

Biopsy/Ablation - CONTROL GROUP

The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded by pushing the start button again.

Biopsy/Ablation - STUDY GROUP:

The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. The physician will then be un-blinded and shown the PercuNav screen and will correct the desired approach path and another screen capture will be taken. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded. At the end of the procedure, and if clinically indicated, a verification "CT" computed tomography scan will be taken with the needle in place and, sent to the PercuNav. Radiation dosage, due to CT imaging, will also be recorded.

Detailed Description:

The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with "US" ultrasound or "CT" computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients.

Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Hospitals and Out-patient Clinics

Criteria

Inclusion Criteria:

Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis;
Is over the age of 18;
Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

Was precluded from a biopsy/ablation procedure based on standard exclusions;
Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
Has a pacemaker or automatic implantable cardiac defibrillator;
Has a gross body weight above the procedural table limit (typically > 170 kg);
Is pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279148

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tina Cooper 843-876-5544 cooperti@musc.edu
Principal Investigator: Marcelo Guimaraes, MD

Sponsors and Collaborators

Philips Healthcare

More Information

No publications provided

Responsible Party:	Philips Healthcare
ClinicalTrials.gov Identifier:	NCT01279148 History of Changes
Other Study ID Numbers:	2010 MCT V7
Study First Received:	January 10, 2011
Last Updated:	May 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Philips Healthcare:

biopsy guidance
tracking device

ClinicalTrials.gov processed this record on May 22, 2013