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Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

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ClinicalTrials.gov Identifier: NCT01287013
Recruitment Status : Terminated (Investigator left NIH)
First Posted : February 1, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Global Positioning Satellite (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 or disease Intervention/treatment
Infection Cancer Neoplasm Empyema Granuloma Device: Cone-beam computed tomography (CT) Device: Conventional Computed Tomography (CT)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
Study Start Date : January 2011
Primary Completion Date : August 2015
Study Completion Date : August 2015
Arms and Interventions

Arm Intervention/treatment
Cone Beam CT
Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
Device: Cone-beam computed tomography (CT)
Imaging
Other Names:
  • XperCT (Philips, Best)
  • XperGuide CT
Conventional CT
Procedure performed with Conventional Computed Tomography (CT) image guidance
Device: Conventional Computed Tomography (CT)
Imaging
Other Name: Conventional CT (Philips)


Outcome Measures

Primary Outcome Measures :
  1. Comparing the Accuracy of Final Device Tip Position [ Time Frame: 1 hour ]
    To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.

  2. Accuracy of Final Device Path (Vector) [ Time Frame: 1 hour ]
    Comparing the accuracy of the path the biopsy needle took to get to the site

  3. Radiation Doses Between Xperguide and Conventional CT [ Time Frame: 1 hour ]
    Comparing radiation doses to determine if there is a change in the dose between the two interventions


Secondary Outcome Measures :
  1. Compare the Number of Repositioning Maneuvers [ Time Frame: 1 hour ]
    To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.

  2. Rates of Definitive Pathologic Diagnosis [ Time Frame: 1 hour ]
    Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287013


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01287013     History of Changes
Other Study ID Numbers: 110082
110082 ( Other Identifier: NIH Clinical Center )
First Posted: February 1, 2011    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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:
Granuloma
Empyema
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Suppuration
Infection
Inflammation