Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
|ClinicalTrials.gov Identifier: NCT01287013|
Recruitment Status : Terminated (Investigator left NIH)
First Posted : February 1, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
- 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.
- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.
- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.
- 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|
|Infection Cancer Neoplasm Empyema Granuloma||Device: Cone-beam computed tomography (CT) Device: Conventional Computed Tomography (CT)|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures|
|Study Start Date :||January 2011|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
Cone Beam CT
Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
Device: Cone-beam computed tomography (CT)
Procedure performed with Conventional Computed Tomography (CT) image guidance
Device: Conventional Computed Tomography (CT)
Other Name: Conventional CT (Philips)
- Comparing the Accuracy of Final Device Tip Position [ Time Frame: 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.
- Accuracy of Final Device Path (Vector) [ Time Frame: 1 hour ]Comparing the accuracy of the path the biopsy needle took to get to the site
- Radiation Doses Between Xperguide and Conventional CT [ Time Frame: 1 hour ]Comparing radiation doses to determine if there is a change in the dose between the two interventions
- Compare the Number of Repositioning Maneuvers [ Time Frame: 1 hour ]To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.
- Rates of Definitive Pathologic Diagnosis [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287013
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Bradford Wood, M.D.||National Institutes of Health Clinical Center (CC)|