An interventional study of 3D Slicer and Monaco in Urologic Cancer and Lymph Node Metastasis, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
Device: 3D Slicer · Device: Monaco
Navigational device used during surgery to locate abnormal lymph nodes.
Navigational device used during surgery to locate abnormal lymph nodes.
Proportion of Patients Completing Intended Procedure (Feasibility)
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.
Time frame: One month, up to 45 days after registration
Proportion of Patients with Laparoscopic Videos Recorded
During the first phase of the project on 10 patients, we will store real-time laparoscopic videos using the KARL STORZ 3D Video system that can be analyzed offline. During the second phase of 10 patients, we will provide an optional video overlay option in the navigation system. The navigation system will be similar to that used on the first 10 patients. The only difference will be that the virtual endoscopy view will be overlaid on the laparoscopy video in the 3D Slicer navigation system.
Time frame: One month, up to 45 days from registration
Path length Kinematic Metric
The kinematic metric of path length will be computed using recorded data from the navigation system. Mean path length scores for all patients will be reported for each kinematic measure.
Time frame: One month, up to 45 days after registration
Velocity Kinematic Metric
The kinematic metric of velocity will be computed using recorded data from the navigation system. Mean velocity scores for all patients will be reported for each kinematic measure.
Time frame: One month, up to 45 days after registration
Acceleration Kinematic Metric
The kinematic metric of acceleration will be computed using recorded data from the navigation system. Mean acceleration scores for all patients will be reported for each kinematic measure.
Time frame: One month, up to 45 days after registration
Jerk Kinematic Metric
The kinematic metric of jerk will be computed using recorded data from the navigation system. Mean jerk scores for all patients will be reported for each kinematic measure.
Time frame: One month, up to 45 days after registration
Mental/Physical/Temporal Demand on Physician
The mental, physical and temporal demand on physicians will be assessed using the NASA Task Load Index (NASA-TLX), a multidimensional assessment tool that rates perceived workload in order to assess the performance of a task. The NASA task load index has a scoring range of 1 to 10 for mental demand, physical demand, temporal demand, effort, and frustration with 1 representing a very low value and 10 representing a very high value. A mean score out of 10 will be given for each operation and a mean score for all 20 operations will be given (out of 10). Assessment will be filled out by investigators.
Time frame: One month, up to 45 days after registration
Mean absolute difference in distance from Instruments to Organs
The accuracy of localization of the organs will be quantified by pointing to specific structures and evaluating the distance of the registered instrument from the structures in the image space.
Time frame: 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.
To ensure quality control of the procedure, the lymph node removed with the navigation system will be compared to the other lymph nodes resected in urologic regions of interest without the use of the navigation system. The unit of measure will be the accuracy of targeting the PET-avid lymph node as confirmed by pathology, i.e., binary decision variable for two categories (using the navigation system or not). Using the navigation system: malignant or not, versus not using with the navigation system: malignant or not. The measurement tool will be the pathological analysis.
Time frame: One month, up to 45 days after registration
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
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