The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131 that has radioactivity, to measure how long it takes for the drug to be absorbed and passed out of the body, and to measure how much radioactivity is absorbed into different tissues of the body.
Iobenguane, which is also known as MIBG, has been used in many patients who have types of cancers caused by what are known as neuroendocrine tumors, such as pheochromocytoma, paraganglioma, and carcinoid. Iobenguane is absorbed by neuroendocrine tumor cells. The radioactive portion of the study drug, Ultratrace iobenguane, is a form of iodine called I 131. The I 131 is absorbed into the tumor with the iobenguane, and the radioactivity should kill the tumors. The type of iobenguane being studied is called Ultratrace because of the new way in which this form of iobenguane is made. This study is the first time in which Ultratrace iobenguane will be given to patients. The purpose of the study is to give a low dose of iobenguane just to find out if the drug is safe, to measure how long it takes the drug to be absorbed and passed out of the body, and to see how much radioactivity is absorbed by different types of tissues of the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
whole body imaging immediately post-dose
whole body imaging 1 hour post-dose
whole body imaging 3 hours post-dose
whole body imaging 6 hours post-dose
whole body imaging 24 hours post-dose
whole body imaging 48 hours post-dose
whole body imaging 120 hours post-dose
blood and urine samples pre-dose
blood and urine samples immediately post-dose
blood and urine samples 1 hour post-dose
blood and urine samples 3 hours post-dose
blood and urine samples 6 hours post-dose
blood and urine samples 24 hours post-dose
blood and urine samples 48 hours post-dose
blood and urine samples 120 hours post-dose
continuous urine samples at intervals of 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 72-96 hours and 96-120 hours post-dose
monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose
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