Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT01287013
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection; Cancer; Neoplasm; Empyema; Granuloma	Device: Cone-beam computed tomography (CT); Device: Conventional Computed Tomography (CT)	N/A

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:

1. Pilot trial:

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

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

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

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Comparing the Accuracy of Final Device Tip Position [1 hour]

   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.

2. Accuracy of Final Device Path (Vector) [1 hour]

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

3. Radiation Doses Between Xperguide and Conventional CT [1 hour]

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

Secondary Outcome Measures

1. Compare the Number of Repositioning Maneuvers [1 hour]

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

2. Rates of Definitive Pathologic Diagnosis [1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

• Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Laganà 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. Review.
• 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.

• Responsible Party: National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT01287013
• Other Study ID Numbers: 110082; 110082
• First Posted: Feb 1, 2011
• Last Update Posted: Jan 5, 2018
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• 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: Empyema; Granuloma

Study Results

Participant Flow

Recruitment Details	Recruitment period = 2/4/2011 - 5/15/2014 Recruitment location = Interventional Radiology Clinic, Department of Radiology and Imaging Sciences, Clinical Center, NIH
Pre-assignment Detail	The PILOT Arm of the study was done prior to enrolling participants in the main phase of the study. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. Participants enrolled in the PILOT Arm were not randomized to either the Cone Beam CT or Conventional CT Arms and not included in the analysis.

Arm/Group Title	Cone Beam CT	Conventional CT	PILOT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance	Procedures performed with Xperguide without randomization to familiarize operators.
Period Title: Overall Study
STARTED	32	34	21
COMPLETED	29	29	0
NOT COMPLETED	3	5	21

Baseline Characteristics

Arm/Group Title	Cone Beam CT	Conventional CT	PILOT	Total
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance	Procedures performed with Xperguide without randomization to familiarize operators.	Total of all reporting groups
Overall Participants	32	34	21	87
Age (Count of Participants)
<=18 years	0 0%	0 0%	1 4.8%	1 1.1%
Between 18 and 65 years	25 78.1%	25 73.5%	8 38.1%	58 66.7%
>=65 years	7 21.9%	9 26.5%	12 57.1%	28 32.2%
Sex: Female, Male (Count of Participants)
Female	18 56.3%	8 23.5%	4 19%	30 34.5%
Male	14 43.8%	26 76.5%	17 81%	57 65.5%

Outcome Measures

1. Primary Outcome

Title	Comparing the Accuracy of Final Device Tip Position
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cone Beam CT	Conventional CT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance
Measure Participants	29	29
Mean (Standard Deviation) [mm]	4.9 (4.1)	12.2 (8.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cone Beam CT, Conventional CT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Accuracy of Final Device Path (Vector)
Description	Comparing the accuracy of the path the biopsy needle took to get to the site
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cone Beam CT	Convetional CT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance
Measure Participants	29	29
Mean (Standard Deviation) [mm]	8.8 (5.4)	28.3 (20.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cone Beam CT, Conventional CT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Radiation Doses Between Xperguide and Conventional CT
Description	Comparing radiation doses to determine if there is a change in the dose between the two interventions
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cone Beam CT	Conventional CT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance
Measure Participants	29	29
Mean (Standard Deviation) [mGy]	53.3 (33.3)	75.4 (62.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cone Beam CT, Conventional CT
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.04
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Compare the Number of Repositioning Maneuvers
Description	To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cone Beam CT	Conventional CT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance
Measure Participants	29	29
Mean (Standard Deviation) [number of repositioning maneuvers]	0.3 (0.5)	1.9 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cone Beam CT, Conventional CT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Rates of Definitive Pathologic Diagnosis
Description	Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cone Beam CT	Conventional CT
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Procedure performed with Conventional Computed Tomography (CT) image guidance
Measure Participants	29	29
Number [percent of accuracy]	93.9	90.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cone Beam CT, Conventional CT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.67
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	1 day
Arm/Group Title	Cone Beam CT		Conventional CT		Pilot Arm
Arm/Group Description	Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation		Procedure performed with Conventional Computed Tomography (CT) image guidance		Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.
All Cause Mortality
	Cone Beam CT		Conventional CT		Pilot Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)		0/21 (0%)
Serious Adverse Events
	Cone Beam CT		Conventional CT		Pilot Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		1/29 (3.4%)		0/21 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/29 (0%)	0	1/29 (3.4%)	1	0/21 (0%)	0
Other (Not Including Serious) Adverse Events
	Cone Beam CT		Conventional CT		Pilot Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.