Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Comparing the Accuracy of Final Device Tip Position
研究概览
简要总结
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.
详细描述
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
- The primary aims are:
a. Pilot trial:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •they are over 18 years of age
- •they are scheduled for image guided procedure
- •the lesion is not superficial (deeper than 3 cm)
排除标准
- •patients with an altered mental status that precludes understanding or consenting for the procedure
- •patients unable to hold reasonably still on a procedure table for the length of the procedure
- •patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
- •patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
研究组 & 干预措施
Cone Beam CT
Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
干预措施: Cone-beam computed tomography (CT) (Device)
Conventional CT
Procedure performed with Conventional Computed Tomography (CT) image guidance
干预措施: Conventional Computed Tomography (CT) (Device)
结局指标
主要结局
Comparing the Accuracy of Final Device Tip Position
时间窗: 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)
时间窗: 1 hour
Comparing the accuracy of the path the biopsy needle took to get to the site
Radiation Doses Between Xperguide and Conventional CT
时间窗: 1 hour
Comparing radiation doses to determine if there is a change in the dose between the two interventions
次要结局
- Compare the Number of Repositioning Maneuvers(1 hour)
- Rates of Definitive Pathologic Diagnosis(1 hour)