Recruiting

3D Slicer & Siemens

Sponsor:

Brigham and Women's Hospital

Code:

NCT05132283

Conditions

Urologic Cancer

Lymph Node Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D Slicer

Monaco

Study Details

Brief 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.

Conditions

Urologic Cancer

Lymph Node Metastasis

Study ID

NCT05132283

Start date

Apr 1, 2022

Status verified date

Jul, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Urologic Lymphadenectomy in AMIGO

Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).

Interventions

3D Slicer

Navigational device used during surgery to locate abnormal lymph nodes.

Monaco

Navigational device used during surgery to locate abnormal lymph nodes.

Primary outcome measure

  • Proportion of Patients Completing Intended Procedure (Feasibility) [ Time Frame: One month, up to 45 days after registration ]

Central Contacts and Locations

Central contacts

Matthew Mossanen, MD

(617) 732-6384mmossanen@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Matthew Mossanen, MD

(617) 732-6384mmossanen@bwh.harvard.edu

Principal Investigator:

Matthew Mossanen, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Urologic Cancer
  • Lymph Node Metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-14.