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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: June 25, 2014
Last verified: May 2014
  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: 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:


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: 277
Study Start Date: January 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
will have the procedure performed with Xperguide
Device: Xperguide CT
Imaging
Group B
will have the procedure performed with regularCT
Device: Computed Tomography
Imaging

  Show Detailed Description

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Nadine Abi-Jaoudeh, 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, 11-CC-0082
Study First Received: January 25, 2011
Last Updated: June 25, 2014
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:
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014