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Comparing Navigation With Xperguide vs. Electromagnetic Tracking vs. Conventional Methods During Percutaneous Image Guided Procedures

This study is currently recruiting participants.
Verified July 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01287013
First received: January 25, 2011
Last updated: May 1, 2013
Last verified: July 2012
History of Changes
  Purpose

Background:

- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a GPS device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach.

Objectives:

- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.

Eligibility:

- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.

Design:

  • Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment.
  • After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking.
  • Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
  • Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
  • Standard post-procedure followup care will be given after the study procedure is completed.

Condition Intervention Phase
Infection
Cancer
Neoplasm
Empyema
Granuloma
 Device: Xperguide CT
Device: Electromagnetic Tracking
Device: Computed Tomography
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Comparing Xperguide to conventional imaging (superiority design) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Comparing Xperguide to EM tracking (equivalence design) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare total time of procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To compare time to target-To compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 297
Study Start Date: January 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Xperguide CT
    N/A
    Device: Electromagnetic Tracking
    N/A
    Device: Computed Tomography
    N/A
Detailed Description:

The initial phase of this trial is a pilot study. In the pilot study, each operator must complete at least 5 cases using Xperguide. This will ensure familiarity with outcome measures for fair comparison. When one of the operators reaches the minimal number of cases, the main trial may begin. However to enroll patients in the main trial, an operator must have personally completed the minimal number of cases with the case report forms.

The main trial is a prospective randomized trial comparing several novel navigation tools with conventional imaging during percutaneous image guided procedures such as biopsies and ablations. Specifically we will compare Xperguide with conventional CT and Xperguide with EM tracking. Xperguide is a navigation tool that utilizes a cone beam CT (CBCT) obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures.

Currently for non-vascular procedures such as biopsies and ablations, a consult is obtained prior to the procedure and an interventional radiologist determines feasibility and imaging guidance for the procedure. The procedure is then scheduled. If the procedure is CT guided, then the participant is eligible for this trial. Randomization occurs when eligibility has been met and consent signed. Block randomization will be used to ensure equal number of patients per group. If the patient is scheduled for repeat (paired) procedures i.e. pre and post treatment then that randomization will determine the modality used during the initial visit and the participant will be automatically assigned to the other modality for the repeat procedure. These patients will be randomized to one of two groups:

Group 1: Xperguide for the initial procedure and CT guided for the second procedure

Group 2: CT guidance for the initial procedure and Xperguide for the second procedure

In the second phase, patients will be randomized to EM tracking or Xperguide navigation. Again if the patient is scheduled to have repeated procedures, the randomization will determine the guidance for the initial procedure and the second procedure will be performed using the other method. Therefore participants will be randomized to two potential groups:

Group 1: Xperguide for the initial procedure and EM tracking for the second procedure

Group 2: EM tracking for the initial procedure and Xperguide for the second procedure

For the non-vascular procedures, CBCT (Cone Beam CT) offers CT like images, Xperguide uses those images to guide needle positioning for biopsy and ablation, but direct comparison has not been done to either conventional guidance or to EM tracking. The key portions of the procedure will not be altered, but the method will be pre-selected by randomization. There is no strong data that one of these methods is superior to the other. It is important to determine optimal guidance during image guided procedures to reduce radiation, improve outcomes and minimize complications. EM tracking has already been used at the clinical center for over 185 cases for the areas studied in this trial.

  Eligibility

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

  • INCLUSION CRITERIA:

    1. they are over 18 years of age
    2. they are scheduled for image guided procedure
    3. the lesion is not superficial (deeper than 3 cm)

EXCLUSION CRITERIA:

  1. patients with an altered mental status that precludes understanding or consenting for the procedure
  2. patients unable to hold reasonably still on a procedure table for the length of the procedure
  3. patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
  4. patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
  5. pregnancy
  6. patients with uncorrectable coagulopathies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287013

Contacts
Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov
Contact: Nadine Abi-Jaoudeh, M.D. (301) 402-1386 abijaoudehn@mail.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
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Nadine Abi-Jaoudeh, M.D. 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:

Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01287013     History of Changes
Other Study ID Numbers: 110082, 11-CC-0082
Study First Received: January 25, 2011
Last Updated: May 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Image Guided Procedures
Xperguide CT
Electromagnetic Tracking
Navigation
 Image Guided Procedure
Cancer
Granuloma

Additional relevant MeSH terms:
Neoplasms
Empyema
Granuloma
Suppuration
Infection
 Inflammation
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013