Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

NCT01287013 | Terminated Results DMC FDA Device

• 1 other identifier: 110082
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Cancer; Neoplasm; Empyema; Granuloma

Keywords

Image Guided Procedures; Xperguide CT; Electromagnetic Tracking; Navigation; Image Guided Procedure; Cancer; Granuloma

Outcome Measures

Primary Outcomes (3)

• Comparing the Accuracy of Final Device Tip Position

  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.

  1 hour

• Accuracy of Final Device Path (Vector)

  Comparing the accuracy of the path the biopsy needle took to get to the site

  1 hour

• Radiation Doses Between Xperguide and Conventional CT

  Comparing radiation doses to determine if there is a change in the dose between the two interventions

  1 hour

Secondary Outcomes (2)

• Compare the Number of Repositioning Maneuvers

  1 hour

• Rates of Definitive Pathologic Diagnosis

  1 hour

Study Arms (2)

Cone Beam CT

OTHER

Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation

Device: Cone-beam computed tomography (CT)

Conventional CT

OTHER

Procedure performed with Conventional Computed Tomography (CT) image guidance

Device: Conventional Computed Tomography (CT)

Interventions

Cone-beam computed tomography (CT) DEVICE

Imaging

Also known as: XperCT (Philips, Best), XperGuide CT

Cone Beam CT

Conventional Computed Tomography (CT) DEVICE

Imaging

Also known as: Conventional CT (Philips)

Conventional CT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with an altered mental status that precludes understanding or consenting for the procedure
• patients unable to hold reasonably still on a procedure table for the length of the procedure
• patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
• patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Lagana D, Fugazzola C. Microwave ablation therapy for treating primary and secondary lung tumours: technical note. Radiol Med. 2010 Sep;115(6):962-74. doi: 10.1007/s11547-010-0547-7. Epub 2010 Mar 29. English, Italian.

  PMID: 20352357 BACKGROUND

• Racadio JM, Babic D, Homan R, Rampton JW, Patel MN, Racadio JM, Johnson ND. Live 3D guidance in the interventional radiology suite. AJR Am J Roentgenol. 2007 Dec;189(6):W357-64. doi: 10.2214/AJR.07.2469.

  PMID: 18029850 BACKGROUND

• Spelle L, Ruijters D, Babic D, Homan R, Mielekamp P, Guillermic J, Moret J. First clinical experience in applying XperGuide in embolization of jugular paragangliomas by direct intratumoral puncture. Int J Comput Assist Radiol Surg. 2009 Nov;4(6):527-33. doi: 10.1007/s11548-009-0370-6. Epub 2009 Jun 13.

  PMID: 20033329 BACKGROUND

• Abi-Jaoudeh N, Fisher T, Jacobus J, Skopec M, Radaelli A, Van Der Bom IM, Wesley R, Wood BJ. Prospective Randomized Trial for Image-Guided Biopsy Using Cone-Beam CT Navigation Compared with Conventional CT. J Vasc Interv Radiol. 2016 Sep;27(9):1342-1349. doi: 10.1016/j.jvir.2016.05.034. Epub 2016 Jul 25.

  PMID: 27461586 RESULT

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Infections; Neoplasms; Empyema; Granuloma

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Results Point of Contact

• Title: Bradford Wood, MD
• Organization: National Institutes of Health

bwood@nih.gov

(301) 496-7739

Study Officials

• Bradford Wood, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 1, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 5, 2018
• Results First Posted: January 5, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)