ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid

Pheochromocytoma Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoid
• Carcinoid Tumor
• Paraganglioma
• Pheochromocytoma

• NCT number: NCT00339131
• Study type: Interventional
• Source: Molecular Insight Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: June 2006
• Completion date: January 2007