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Generated: June 19, 2019

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CLINICAL TRIALS PROFILE FOR IOBENGUANE I-131

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Clinical Trials for Iobenguane I-131

Trial ID Title Status Sponsor Phase Summary
NCT00126425 Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease Completed GE Healthcare Phase 3 The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.
NCT00339131 ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid Completed Molecular Insight Pharmaceuticals, Inc. Phase 1 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.
NCT00458952 Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma Completed Molecular Insight Pharmaceuticals, Inc. Phase 1/Phase 2 The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.
NCT00659984 N2007-01: Ultratraceā„¢ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma Completed Molecular Insight Pharmaceuticals, Inc. Phase 2 RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG. PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.
NCT00730444 Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma Approved for marketing GE Healthcare N/A GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for [123I]mIBG imaging.
NCT00992173 Efficacy and Safety of Ultratraceā„¢ Iobenguane I 131 in Neuroblastoma Withdrawn Molecular Insight Pharmaceuticals, Inc. Phase 2 This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die. In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.
NCT01019850 N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Iobenguane I-131

Condition Name

Condition Name for Iobenguane I-131
Intervention Trials
Neuroblastoma 5
Paraganglioma 3
Pheochromocytoma 3
Disseminated Neuroblastoma 1
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Condition MeSH

Condition MeSH for Iobenguane I-131
Intervention Trials
Neuroblastoma 7
Pheochromocytoma 3
Paraganglioma 3
Carotid Body Tumor 3
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Clinical Trial Locations for Iobenguane I-131

Trials by Country

Trials by Country for Iobenguane I-131
Location Trials
United States 60
Canada 1
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Trials by US State

Trials by US State for Iobenguane I-131
Location Trials
Texas 6
Pennsylvania 6
North Carolina 5
Ohio 4
Michigan 4
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Clinical Trial Progress for Iobenguane I-131

Clinical Trial Phase

Clinical Trial Phase for Iobenguane I-131
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Iobenguane I-131
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 1
Not yet recruiting 1
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Clinical Trial Sponsors for Iobenguane I-131

Sponsor Name

Sponsor Name for Iobenguane I-131
Sponsor Trials
Molecular Insight Pharmaceuticals, Inc. 5
National Cancer Institute (NCI) 4
GE Healthcare 3
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Sponsor Type

Sponsor Type for Iobenguane I-131
Sponsor Trials
Industry 11
Other 5
NIH 4
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