Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

Recurrent Renal Cell Cancer Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01281488
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2011
• Completion date: October 9, 2017