Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urologic Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of Patients Completing Intended Procedure (Feasibility)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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. It will take you up to 4 weeks to complete this study. During that time you will have two study visits and one standard of care follow-up visit. The research study procedures include: screening for eligibility and study treatment including evaluations and standard of care follow-up visits. It is expected that about 20 people will take part in this research study.
Investigators
Matthew Mossanen, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Proportion of Patients Completing Intended Procedure (Feasibility)
Time Frame: 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.
Secondary Outcomes
- 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)