Using advanced navigation systems for lymph node surgery in urologic cancer
Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
This study is testing if using advanced navigation systems during lymph node surgery can help improve outcomes for patients with urologic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05132283 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed or suspected diagnosis of urologic cancer requiring lymphadenectomy.
Not a fit: Patients with severely impaired renal function or significant uncontrolled comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and fewer complications for patients undergoing lymphadenectomy for urologic cancer.
How similar studies have performed: While the use of navigation systems in surgery is a growing field, this specific application in urologic lymphadenectomy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.