Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339131
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2006-06-17
Brief Title:
ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma Paraganglioma or Metastatic Carcinoid
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
Phase 1 Study Evaluating the Safety Distribution Metabolism and Radiation Dosimetry of ULTRATRACE Iobenguane I 131 in Patients With Malignant PheochromocytomaParaganglioma or Metastatic Carcinoid
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None