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
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Among 58 studies in Urologic Neoplasms with a site in United States — 10 open to participants now, 18 under way, 3 of them phase 3. Urologic Neoplasms · United States.
Among the 58 studies in Urologic Neoplasms with a site in United States, this one is the 37th largest by planned enrollment of the 49 interventional ones that give a count, is one of 4 that started in 2022, is one of 7 with no phase, reaches primary completion later than 14 of the 17 other live ones, and was the 44th registered.
155 studies on the registry are indexed under Urologic Neoplasms; 40 are open to participants now.
Browse Urologic Neoplasms studies →10 of the 58 studies in Urologic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Astellas Pharma Global Development, Inc. · Sites in United States, Canada, Korea, Republic of and 1 more country
Ages 18+
Duke University · Sites in United States
Ages 18+ · Women only
Eli Lilly and Company · Sites in United States, Australia, China and 5 more countries
Ages 18+
UroGen Pharma Ltd. · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Urologic Neoplasms studies recruiting now, 24 (80%) set no upper age limit and 2 (7%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 22 · Phase 3 6 · Phase 4 2
First in 1998; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 60 across 109 interventional studies indexed under Urologic Neoplasms.
Median enrollment 54 across the 49 interventional studies, 475 across the 4 observational. Of the 39 that completed or were terminated, 14 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 58 have an industry lead sponsor. The 10 most frequent:
Brigham and Women's Hospital is the lead sponsor of 1,268 studies on the registry; 229 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Brigham and Women's Hospital has 2 studies filed under Urologic Neoplasms — fewer than ten, so there is no comparison to draw.
9 of the studies in Urologic Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT05544552Tyra Biosciences, IncSafety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations | 2026-11 |
| NCT02379429National Cancer Institute (NCI)Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue | 2027-01-01 |
| NCT06238479Eli Lilly and CompanyA Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT06465069Eli Lilly and CompanyA Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors | 2027-05 |
Add all 9 to your calendar (.ics) → With an account.
Among the 58 studies in Urologic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Informed consent form
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Dec 2027, 68 months after the start.
Of 23 interventional studies with no phase under Urologic Neoplasms, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 68 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Aug 2026 → Dec 2027 and completion Sep 2026 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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