Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

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.

Inclusion Criteria:

- Patients with a computed tomography (CT) scan or magnetic resonance imaging (MRI) on
preoperative assessment showing evidence of a renal cortical tumor; the renal tumor
must be stage T1a/bT2

- Due to concerns of surgical and anesthetic effects on the fetus, women of child
bearing age who are considered to still be fertile must undergo a urine pregnancy test
prior to inclusion in the study; only women with negative urine pregnancy tests prior
to surgery will be included; if a women is found to have a positive urine pregnancy
test, surgery and potential inclusion in the study will be deferred until after
delivery of the baby; should a woman become pregnant or suspect that she is pregnant
prior to surgical management, she should inform her treating physician immediately;
although it is known that ICG is released from the body through the hepatic system,
breastfeeding mothers will be excluded from the study due to the unknown side effects
on the infant in the breastfeeding population

- The subject must be able to comply with the study procedures

- All subjects must have the ability to understand the risks, benefits, and alternatives
of the study and the willingness to sign a written informed consent

Exclusion Criteria:

- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal
liver function tests, as total bilirubin greater than 1.5 X normal and/or serum
glutamic oxaloacetic transaminase (SGOT) greater than 2 X normal

- Subject has uremia, serum creatinine greater than 2.0 mg/dl

- Subject has previous history of adverse reaction or allergy to ICG, iodine, shellfish
or iodine dyes

- Subject in whom the use of x ray dye or ICG is contraindicated including development
of adverse events when previously or presently administered

- Subject has any medical condition, which in the judgment of the Investigator and/or
designee makes the subject a poor candidate for the investigational procedure

- Subject is actively participating in another drug, biologic and/or device protocol

- The presence of medical conditions contraindicating general anesthesia or standard
surgical approaches

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study