Trial Information

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

PR 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: 3 years

Number of sites: 1

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