Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator left NIH
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Empyema | — | UNRESOLVED | — |
| Granuloma | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cone-beam computed tomography (CT) | Device | — | UNRESOLVED |
| Conventional Computed Tomography (CT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cone Beam CT
- description
- Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
- interventionNames
- Device: Cone-beam computed tomography (CT)
- type
- OTHER
- label
- Conventional CT
- description
- Procedure performed with Conventional Computed Tomography (CT) image guidance
- interventionNames
- Device: Conventional Computed Tomography (CT)
Primary outcomes (3)
- measure
- Comparing the Accuracy of Final Device Tip Position
- timeFrame
- 1 hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* 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)
References
Publications (4)
- BACKGROUNDCarrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Lagana 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. PMID 20352357
- BACKGROUNDRacadio 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. doi: 10.2214/AJR.07.2469. PMID 18029850
- BACKGROUNDSpelle 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. PMID 20033329
- RESULTAbi-Jaoudeh N, Fisher T, Jacobus J, Skopec M, Radaelli A, Van Der Bom IM, Wesley R, Wood BJ. Prospective Randomized Trial for Image-Guided Biopsy Using Cone-Beam CT Navigation Compared with Conventional CT. J Vasc Interv Radiol. 2016 Sep;27(9):1342-1349. doi: 10.1016/j.jvir.2016.05.034. Epub 2016 Jul 25. PMID 27461586