Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

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

Interventions

DEVICE

Cone-beam computed tomography (CT)

Imaging

DEVICE

Conventional Computed Tomography (CT)

Imaging

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC)

  lead NIH

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2015-08-31

Completion

2015-08-31

FDA Device

Yes

Countries

• United States

Study Locations