Lutathera in Somatostatin Neuroendocrine Tumors
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Description
This study involves taking a study drug called Lutathera.The overall goal of this study is to see if Lutathera is safe in adolescentsubjects with either a gastroenteropancreatic neuroendocrine tumor (GEP-NET),or a pheochromocytoma and/or paraganglioma (PPGL). This study will also look atthe levels of radioactivity after Lutathera administration.
Eligibility and criteria
What to expect
This study will enroll male and female patients between 12and 18 years of age that have been diagnosed with either agastroenteropancreatic neuroendocrine tumor (GEP-NET), or a pheochromocytomaand/or paraganglioma (PPGL) that has spread (metastasized) or cannot becompletely removed by surgery. Subjects will receive Lutathera viaintravenous (IV) infusion. Lutathera is a drug that is taken up by GEP-NETs andPPGLs and emits radiation to attempt to prevent growth of the cancer cells. To protect the kidneys from radiation, an amino acid solution will alsobe administered with each Lutathera dose. Study visits will also include thefollowing assessments: electrocardiograms (ECGs), urine tests, blood tests,SPECT/CT imaging, and whole body planar imaging.
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