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Recruiting
NCT05132283
Urologic Lymphadenectomy in AMIGO
Conditions: Urologic Cancer, Lymph Node Metastasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
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.
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
Source: ClinicalTrials.gov (NCT05132283). StuddyBuddy aggregates publicly available trial information.