Comparing Navigation With Xperguide vs. Electromagnetic Tracking vs. Conventional Methods During Percutaneous Image Guided Procedures
- 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 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.
Device: Xperguide CT
Device: Electromagnetic Tracking
Device: Computed Tomography
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures|
- Comparing Xperguide to conventional imaging (superiority design) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Comparing Xperguide to EM tracking (equivalence design) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- To compare total time of procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- To compare time to target-To compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- To compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Device: Xperguide CT
The initial phase of this trial is a pilot study. In the pilot study, each operator must complete at least 5 cases using Xperguide. This will ensure familiarity with outcome measures for fair comparison. When one of the operators reaches the minimal number of cases, the main trial may begin. However to enroll patients in the main trial, an operator must have personally completed the minimal number of cases with the case report forms.
The main trial is a prospective randomized trial comparing several novel navigation tools with conventional imaging during percutaneous image guided procedures such as biopsies and ablations. Specifically we will compare Xperguide with conventional CT and Xperguide with EM tracking. 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.
Currently for non-vascular procedures such as biopsies and ablations, a consult is obtained prior to the procedure and an interventional radiologist determines feasibility and imaging guidance for the procedure. The procedure is then scheduled. If the procedure is CT guided, then the participant is eligible for this trial. Randomization occurs when eligibility has been met and consent signed. Block randomization will be used to ensure equal number of patients per group. If the patient is scheduled for repeat (paired) procedures i.e. pre and post treatment then that randomization will determine the modality used during the initial visit and the participant will be automatically assigned to the other modality for the repeat procedure. These patients will be randomized to one of two groups:
Group 1: Xperguide for the initial procedure and CT guided for the second procedure
Group 2: CT guidance for the initial procedure and Xperguide for the second procedure
In the second phase, patients will be randomized to EM tracking or Xperguide navigation. Again if the patient is scheduled to have repeated procedures, the randomization will determine the guidance for the initial procedure and the second procedure will be performed using the other method. Therefore participants will be randomized to two potential groups:
Group 1: Xperguide for the initial procedure and EM tracking for the second procedure
Group 2: EM tracking for the initial procedure and Xperguide for the second procedure
For the non-vascular procedures, CBCT (Cone Beam CT) offers CT like images, Xperguide uses those images to guide needle positioning for biopsy and ablation, but direct comparison has not been done to either conventional guidance or to EM tracking. The key portions of the procedure will not be altered, but the method will be pre-selected by randomization. There is no strong data that one of these methods is superior to the other. It is important to determine optimal guidance during image guided procedures to reduce radiation, improve outcomes and minimize complications. EM tracking has already been used at the clinical center for over 185 cases for the areas studied in this trial.
|Contact: Charisse Garcia, R.N.||(301) firstname.lastname@example.org|
|Contact: Nadine Abi-Jaoudeh, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Nadine Abi-Jaoudeh, M.D.||National Institutes of Health Clinical Center (CC)|