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

Procedure performed with Conventional Computed Tomography (CT) image guidance

Cone-beam computed tomography (CT)

Conventional Computed Tomography (CT)

Bradford Wood, M.D.

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.

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

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

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.

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

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

To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.

Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.

National Institutes of Health Clinical Center (CC)

Cone Beam CT

Conventional CT

Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.

Pilot Arm

Procedures performed with Xperguide without randomization to familiarize operators.

PILOT

Total

Age, Categorical

Sex: Female, Male

Bradford Wood, MD

Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

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