This phase I trial tests the efficiency of the 3D Slicer and the Siemens Monaco system in reducing the morbidity or the likelihood of any medical problems after a lymph node resection (lymphadenectomy) or organ removal in patients with urologic cancers. The navigation systems, 3D Slicer and the Siemens Monaco system, may simplify the complexity of laparoscopic lymphadenectomy (the procedure in which a small incision in the lower abdomen to reach the lymph nodes) or organ removal in regions of urologic interest, by resulting in better visualization and more accurate localization of the diseased area, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05132283.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Matthew Mossanen
Phone: 617-732-6384
PRIMARY OBJECTIVES:
I. Under an institutional review board (IRB)-approved protocol, the feasibility in the use of the Slicer-Monaco prototype navigation platform to resect enlarged, and/or 18F-fluorodeoxyglucose (FDG)-avid lymph nodes, and/or remove urologic organs in 20 patients.
II. Record laparoscopic videos to develop stereo reconstruction algorithms and advanced registration algorithms to compensate for tissue deformation.
III. Analysis of the procedure.
OUTLINE:
Patients undergo a standard of care lymphadenectomy and/or organ removal operation during resection with the use of navigation systems, the 3D Slicer and the Siemens Monaco system, to locate the area of abnormality.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMatthew Mossanen