Phase 1 Study Evaluating the Safety, Distribution, Metabolism, and Radiation Dosimetry of ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma or Metastatic Carcinoid
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
whole body imaging immediately post-dose
Ralph E Coleman, MD
Principal Investigator
Duke University
United States: Food and Drug Administration
MIP-IB11
NCT00339131
June 2006
January 2007
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