Lutathera in Somatostatin Neuroendocrine Tumors

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This study involves taking a study drug called Lutathera. The overall goal of this study is to see if Lutathera is safe in adolescent subjects with either a gastroenteropancreatic neuroendocrine tumor (GEP-NET), or a pheochromocytoma and/or paraganglioma (PPGL). This study will also look at the levels of radioactivity after Lutathera administration.

Eligibility & Criteria

IRB #:
21-018820
Official Title:
A Multicenter Open-Label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients with Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas
Study Phase:
Phase II
Eligible Age Range:
12 - 17 Years
Gender:
All
Study Categories:

Visit Criteria

This study will enroll male and female patients between 12 and 18 years of age that have been diagnosed with either a gastroenteropancreatic neuroendocrine tumor (GEP-NET), or a pheochromocytoma and/or paraganglioma (PPGL) that has spread (metastasized) or cannot be completely removed by surgery. Subjects will receive Lutathera via intravenous (IV) infusion. Lutathera is a drug that is taken up by GEP-NETs and PPGLs and emits radiation to attempt to prevent growth of the cancer cells. To protect the kidneys from radiation, an amino acid solution will also be administered with each Lutathera dose. Study visits will also include the following assessments: electrocardiograms (ECGs), urine tests, blood tests, SPECT/CT imaging, and whole body planar imaging.

Leader
Theodore W. Laetsch

Theodore Laetsch, MD