Clinical trial · Interventional
Urologic Lymphadenectomy in AMIGO
Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
NCT05132283CI-TRIAL-00117824recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Urologic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Slicer | Device | — | UNRESOLVED |
| Monaco | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Urologic Lymphadenectomy in AMIGO
- description
- Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
- interventionNames
- Device: 3D Slicer
- Device: Monaco
Primary outcomes (1)
- measure
- Proportion of Patients Completing Intended Procedure (Feasibility)
- timeFrame
- One month, up to 45 days after registration
- description
- 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 (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.