Using advanced navigation systems for lymph node surgery in urologic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research involves utilizing two advanced navigation systems, the 3D Slicer and Siemens Monaco, to enhance the precision of image-guided lymphadenectomy procedures in patients with urologic cancer. The study aims to simplify the surgical process by improving visualization and localization of affected lymph nodes, potentially leading to better surgical outcomes and reduced complications. Participants will undergo laparoscopic lymphadenectomy with the assistance of these navigation systems, which have not yet received FDA approval for clinical use. The long-term goal is to demonstrate increased efficiency and reduced morbidity associated with lymph node resections in urologic cancer patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Matthew Mossanen, MD — Brigham and Women's Hospital
• Study coordinator: Matthew Mossanen, MD
• Email: mmossanen@bwh.harvard.edu
• Phone: (617) 732-6384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.