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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Recurrent Renal Cell Cancer, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

2 weeks post surgery

Safety Issue:

No

Principal Investigator

Clayton Lau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10155

NCT ID:

NCT01281488

Start Date:

October 2011

Completion Date:

Related Keywords:

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

Name

Location

City of Hope Medical CenterDuarte, California  91010