NCT05132283

Urologic Lymphadenectomy in AMIGO

Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urologic Cancer
• Lymph Node Metastasis

Interventions

Type	Name	Description
DEVICE	3D Slicer	Navigational device used during surgery to locate abnormal lymph nodes.
DEVICE	Monaco	Navigational device used during surgery to locate abnormal lymph nodes.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-08-26
• Completion: 2025-12-26
• First posted: 2021-11-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study