Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

Completed · Phase 1

Conditions studied: Recurrent Renal Cell Cancer, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer

In brief

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

Key facts

Study ID: NCT01281488
Run by: City of Hope Medical Center
People needed: 28
Starts: 2011-10-20
Expected to finish: 2017-10-09
Last updated by the study team: 2017-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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