Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

• Status: Completed
• Trial end date: 2017-10-09
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)

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