Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01281488
First received: January 19, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Recurrent Renal Cell Cancer
Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Procedure: fluorescence imaging
Procedure: laparoscopic surgery
Drug: indocyanine green
Phase 1

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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

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 [ Time Frame: 2 weeks post surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: At surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: At surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (fluorescence imaging and surgery)
Patients undergo NIR fluorescence imaging with ICG on the da Vinci Surgical System followed by standard approach robot-assisted laparoscopic partial nephrectomy.
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
Other Names:
  • laparoscopy-assisted surgery
  • surgery, laparoscopic
Drug: indocyanine green
Given IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01281488

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Clayton Lau, MD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01281488     History of Changes
Other Study ID Numbers: 10155, NCI-2011-00067
Study First Received: January 19, 2011
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014