NCT01281488

Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in planning surgery. PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG) fluorescence imaging in finding tumors in patients with kidney tumors

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 partial nephrectomy. After completion of study treatment, patients are followed up at 1-2 weeks.

Conditions

• Recurrent Renal Cell Cancer
• Stage I Renal Cell Cancer
• Stage II Renal Cell Cancer

Interventions

Type	Name	Description
PROCEDURE	fluorescence imaging	Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
PROCEDURE	laparoscopic surgery	Undergo standard approach robot-assisted laparoscopic partial nephrectomy
DRUG	indocyanine green	Given IV

Timeline

• Start date: 2011-10-20
• Primary completion: 2017-10-09
• Completion: 2017-10-09
• First posted: 2011-01-24
• Last updated: 2017-10-13

Locations

1 site across 1 country: United States