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Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

fluorescence imaging

laparoscopic surgery

indocyanine green

About this trial

This is an interventional treatment trial for Recurrent Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Treatment 1 (fluorescence imaging and surgery)

Treatment 2 (fluorescence imaging and surgery)

Treatment 3 (fluorescence imaging and surgery)

Treatment 4 (fluorescence imaging and surgery)

Treatment 5 (fluorescence imaging and surgery)

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.018 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Patients undergo NIR fluorescence imaging with ICG and an additional 0.036 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Patients undergo NIR fluorescence imaging with ICG and an additional 0.07 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Patients undergo NIR fluorescence imaging with ICG and an additional 0.14 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Patients undergo NIR fluorescence imaging with ICG and an additional 0.21 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive margin from pathology

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.

Total surgical time

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.

Warm ischemia time

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.

Full Information

NCT ID

NCT01281488

First Posted

January 19, 2011

Last Updated

October 11, 2017

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01281488

Brief Title

Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 20, 2011 (undefined)

Primary Completion Date

October 9, 2017 (Actual)

Study Completion Date

October 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment 1 (fluorescence imaging and surgery)

Arm Type

Experimental

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.018 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Arm Title

Treatment 2 (fluorescence imaging and surgery)

Arm Type

Experimental

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.036 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Arm Title

Treatment 3 (fluorescence imaging and surgery)

Arm Type

Experimental

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.07 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Arm Title

Treatment 4 (fluorescence imaging and surgery)

Arm Type

Experimental

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.14 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Arm Title

Treatment 5 (fluorescence imaging and surgery)

Arm Type

Experimental

Arm Description

Patients undergo NIR fluorescence imaging with ICG and an additional 0.21 mg/kg/dose on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.

Intervention Type

Procedure

Intervention Name(s)

fluorescence imaging

Intervention Description

Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system

Intervention Type

Procedure

Intervention Name(s)

laparoscopic surgery

Other Intervention Name(s)

laparoscopy-assisted surgery, surgery, laparoscopic

Intervention Description

Undergo standard approach robot-assisted laparoscopic partial nephrectomy

Intervention Type

Drug

Intervention Name(s)

indocyanine green

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

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

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.

Time Frame

2 weeks post surgery

Secondary Outcome Measure Information:

Title

Positive margin from pathology

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.

Time Frame

2 weeks post-surgery

Title

Total surgical time

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.

Time Frame

At surgery

Title

Warm ischemia time

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.

Time Frame

At surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clayton Lau, MD

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

12. IPD Sharing Statement

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Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

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