Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of Patients Completing Intended Procedure (Feasibility)
研究概览
简要总结
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.
详细描述
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, which will simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes).
The U.S. Food and Drug Administration (FDA) has not approved the navigation systems (3D Slicer and Monaco) as a treatment for any disease.
In this research study, our hypothesis is that the use of the navigation systems (3D Slicer and the Siemens Monaco system) may simplify the complexity of laparoscopic lymphadenectomy (The procedure in which a small incision is made in the lower abdomen to reach the lymph nodes) in regions of urologic interest, by resulting in better visualization and more accurate localization of the diseased lymph node and allowing for improved surgical and patient outcomes, fewer complications, and better clinician performance.
The long-term goal of our program is to demonstrate that the navigation system (3D Slicer and the Siemens Monaco system) increase the efficiency and reduce the morbidity or the likelihood of any medical problems associated with the resection or removal of radiologically defined lesions, within urologic regions of interest, associated with any type of urologic cancer. The first clinical application of the system will be in resecting radiologically positive lymph nodes displayed by CT or FDG PET (an imaging test used to identify lymphomas and other cancers) in the Advanced Multimodality Image-Guided Operating (AMIGO) Suite at Brigham and Women's Hospital (BWH).
The navigation system has been used with similar protocols, specifically 5 parathyroid surgeries, 13 tracked endoscopic ultrasound (minimally invasive procedure to assess digestive and lung diseases) and over 30 tracked colonoscopy experiments (exam used to detect changes or abnormalities in the large intestine (colon) and rectum) on human subjects at BWH with no difficulties or reportable incidents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
- •Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.
- •Subjects must have had a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month.
- •Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile.
- •Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR
排除标准
- •Severely impaired renal function with an EGFR < 30 mL/min/body surface area
- •Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
- •History of hypersensitivity or other contraindication to contrast media
- •Contraindication to general anesthesia
- •Pregnancy
研究组 & 干预措施
Urologic Lymphadenectomy in AMIGO
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
干预措施: 3D Slicer (Device)
Urologic Lymphadenectomy in AMIGO
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
干预措施: Monaco (Device)
结局指标
主要结局
Proportion of Patients Completing Intended Procedure (Feasibility)
时间窗: One month, up to 45 days after registration
The Slicer-Monaco prototype navigation platform will be used to resect enlarged and/or fluorodeoxyglucose avid lymph nodes. The successful navigational use of this platform will be considered as completed. The proportion of patients completing this intended procedure will be reported.
次要结局
- Velocity Kinematic Metric(One month, up to 45 days after registration)
- Path length Kinematic Metric(One month, up to 45 days after registration)
- Proportion of Patients with Laparoscopic Videos Recorded(One month, up to 45 days from registration)
- Acceleration Kinematic Metric(One month, up to 45 days after registration)
- Jerk Kinematic Metric(One month, up to 45 days after registration)
- Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.(One month, up to 45 days after registration)
- Mental/Physical/Temporal Demand on Physician(One month, up to 45 days after registration)
- Mean absolute difference in distance from Instruments to Organs(One month, up to 45 days after registration)
研究者
Matthew Mossanen, MD, MPH
Urologic Surgeon
Brigham and Women's Hospital