- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281488
Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors
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
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment 1 (fluorescence imaging and surgery)
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.
|
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Other Names:
Given IV
|
Experimental: Treatment 2 (fluorescence imaging and surgery)
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.
|
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Other Names:
Given IV
|
Experimental: Treatment 3 (fluorescence imaging and surgery)
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.
|
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Other Names:
Given IV
|
Experimental: Treatment 4 (fluorescence imaging and surgery)
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.
|
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Other Names:
Given IV
|
Experimental: Treatment 5 (fluorescence imaging and surgery)
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.
|
Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
Undergo standard approach robot-assisted laparoscopic partial nephrectomy
Other Names:
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
2 weeks post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive margin from pathology
Time Frame: 2 weeks post-surgery
|
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.
|
2 weeks post-surgery
|
Total surgical time
Time Frame: At surgery
|
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.
|
At surgery
|
Warm ischemia time
Time Frame: At surgery
|
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.
|
At surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Clayton Lau, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10155
- NCI-2011-00067 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Renal Cell Cancer
-
Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
-
National Cancer Institute (NCI)TerminatedSorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney CancerClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell Cancer | Papillary Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Unspecified Adult Solid Tumor, Protocol Specific | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell Cancer | Stage I Renal Cell Cancer | Stage II Renal Cell CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
National Cancer Institute (NCI)TerminatedRenal Cell Carcinoma | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
City of Hope Medical CenterCompletedClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
Jonsson Comprehensive Cancer CenterKite, A Gilead CompanyCompletedClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
Stanford UniversityNational Cancer Institute (NCI)TerminatedClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
Clinical Trials on fluorescence imaging
-
University Health Network, TorontoJudy Dan Research and Treatment CentreCompletedFoot Ulcer, Diabetic | BacteriaCanada
-
Intuitive SurgicalWithdrawnRenal TumorsUnited States
-
University of LeipzigUnknown
-
Oulu University HospitalTurku University Hospital; Tampere University Hospital; University of Oulu; Päijänne... and other collaboratorsRecruitingIndocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage (ICG-COLORAL)Gastrointestinal Neoplasms | Colorectal Neoplasms | Colorectal Cancer | Gastrointestinal Cancer | Diverticulosis, Colonic | Gastrointestinal DiseaseFinland
-
Maastricht University Medical CenterUnknownEndometriosisNetherlands
-
MolecuLight Inc.Completed
-
Saint Petersburg State University, RussiaShandong Linglong Yingcheng HospitalRecruiting
-
The University of Hong KongUnknown
-
Stryker EndoscopyTerminated
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownDiabetic Cardiomyopathies