A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
I. To determine the optimal dose of ICG fluorescence for visualization using the SPY scope
with near infrared (NIR) imaging technology on the da Vinci Surgical System to detect renal
cortical tumors and to assist in their removal.
I. To observe and report peri-operative outcomes, including but not limited to the following
observations: positive surgical margin rate, correlation of the ICG and NIR imaging
technology with intraoperative ultrasound imaging and preoperative imaging, incidence of
adverse events, estimated blood loss, blood transfusion rate, length of stay, time of
operation, utility of ICG and NIR imaging technology to assist in localization of renal
hilar structures, utility of ICG and NIR imaging technology to assist in localization of the
renal mass, warm renal ischemia time measurements, the feasibility of selective renal
arterial clamping with the ICG and NIR imaging technology, cost analysis retrospective
comparisons to patients who underwent similar surgical procedures without the use of ICG and
NIR imaging technology, the overall effect of ICG and NIR imaging technology on
postoperative renal function, and determination of possible future technique variations
using the ICG and NIR imaging technology to improve nephron sparing surgery.
OUTLINE: This is a dose-escalation study. Patients undergo NIR fluorescence imaging with ICG
on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic
After completion of study treatment, patients are followed up at 1-2 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Determination of the optimal dose of ICG which will maximize its utility in the detection of renal cortical tumors by NIR imaging technology on the da Vinci Surgical System
Compared between patients prospectively accrued to the study who had fluorescence imaging and those in the retrospective cohort whose procedures were not assisted with fluorescence imaging.
2 weeks post surgery
Clayton Lau, MD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|