Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Granuloma; Infection; Neoplasm; Empyema
• Intervention / Treatment: Device: Cone-beam computed tomography (CT); Device: Conventional Computed Tomography (CT)

Detailed Description

PR(SqrRoot) CIS

This is a phase II prospective randomized trial comparing a novel navigation method, Xperguide to conventional CT and electromagnetic tracking (EM) during percutaneous image guided procedures. 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. The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance.

SPECIFIC AIMS/OBJECTIVES

1. The primary aims are:

   a. Pilot trial:

   i. To familiarize operators with outcome measures allowing for fair comparison in the subsequent study

   b. Main trial will have 2 phases with similar outcomes criteria and aims (below):

   i. comparing Xperguide to conventional imaging (superiority design):

ii. comparing Xperguide to EM tracking (equivalence design):

1. To compare the accuracy of final device tip position and path (vector)
2. To compare the number of repositioning maneuvers
3. To compare the radiation dose
4. To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations

METHODS/METHODOLOGY

For non-vascular image guided interventions, patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization. An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms. This will ensure experience with outcome measures and fair comparison in the subsequent study. Once one of the operators reaches the minimal required cases, the main trial will begin for that operator. However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial. Initially, we will compare Xperguide with conventional CT with several cohorts of patients mainly: lung biopsies, and ablations, kidney biopsies/ablations and other abdominal biopsies/ ablations. In ablations of large lesions, Xperguide composite ablation software can provide input on the expected ablation zones. Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4. If this specific composite ablation module of the

software is not commercially released and FDA cleared at the time of the study, then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation. Once consent is obtained the participant is randomized to either conventional imaging or Xperguide. In addition, if it is known that the patient is participating in a trial which requires a repeat (paired, pre and post treatment) procedure of the same site, then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure. In these cases, if the patient gives consent they will be randomized to one of two categories:

1. Xperguide for the initial procedure and conventional CT for the 2nd procedure
2. Conventional CT for the initial procedure and Xperguide for the 2nd procedure

Then in the second phase of the trial, Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance, in an equivalence study. Once consent is obtained, the participant will be randomized into EM tracking or Xperguide. The patients would be divided into different cohorts depending on the anatomic site of the interventions i.e. lung, kidney, liver and other abdomen. If the patients are participating in a trial requiring paired procedures (i.e. pre and post treatment), the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure. In summary there will be two potential categories:

1. EM tracking for the initial procedure and Xperguide for the 2nd procedure
2. Xperguide for the initial procedure and EM tracking for the 2nd procedure

If a patient has a lesion that is only visible on PET-CT/MR, or demonstrates heterogenous PET-CT/MR uptake, there will be a separate cohort of PET-CT/MR guided biopsies and ablations using Xperguide vs EM tracking. There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH.

ELIGIBILITY

Subjects are eligible if:

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

Subjects are excluded if:

1. they have an altered mental status that precludes understanding or consenting for the procedure
2. they are unable to hold reasonably still on a procedure table for the length of the procedure
3. they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
4. their gross body weight is over 375 pounds which the upper limit of the CT and

angiography tables

REQUIRED SAMPLE SIZE

A pilot study will be performed to ensure operator experience with Xperguide and EM tracking, for fair comparison. In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms. There are 5 potential operators therefore a maximum of 25 patients (if all 5 operators participate to the fullest).

The first phase of the main trial comparing Xperguide with conventional CT was powered (for sample size) with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT (defined as requiring fewer needle repositioning efforts). These calculations yield a total sample size of 60 patients with 20 patients per anatomical site.

For the second phase of the trial comparing Xperguide to EM tracking, a two sided equivalence design (based on accuracy and number of needle repositioning) was used for sample size considerations, and yielded 192 patients. Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CT/MR procedures and composite ablations.

Number of Participants: 277

Recruitment Time Frame: 4 years

Number of sites: 1

Type of Study: prospective randomized clinical trial after an initial pilot period

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: Conventional CT; Procedure performed with Conventional Computed Tomography (CT) image guidance	Device: Conventional Computed Tomography (CT); Imaging; Other Names: Conventional CT (Philips)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Number of Repositioning Maneuvers	To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.	1 hour
Rates of Definitive Pathologic Diagnosis	Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.	1 hour

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Bradford Wood, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cancer; Navigation; Granuloma; Electromagnetic Tracking; Image Guided Procedures; Xperguide CT; Image Guided Procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Lymphoproliferative Disorders; Lymphatic Diseases; Inflammation; Suppuration; Granuloma; Empyema
• Other Study ID Numbers: 110082 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No