CLINICAL TRIALS PROFILE FOR ADREVIEW
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All Clinical Trials for Adreview
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00730444 ↗ | Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma | Approved for marketing | GE Healthcare | 1969-12-31 | 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. | |
| NCT01522378 ↗ | Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging | Terminated | GE Healthcare | Phase 1 | 2012-02-01 | Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan. |
| NCT01522378 ↗ | Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging | Terminated | Mayo Clinic | Phase 1 | 2012-02-01 | Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan. |
| NCT01868841 ↗ | 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System | Completed | GE Healthcare | Phase 4 | 2013-12-01 | The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system. |
| NCT01868841 ↗ | 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System | Completed | Timothy M. Bateman | Phase 4 | 2013-12-01 | The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system. |
| NCT01936649 ↗ | Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView. | Completed | H2O Clinical LLC | Phase 4 | 2013-08-01 | The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart. |
| NCT01936649 ↗ | Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView. | Completed | Quintiles, Inc. | Phase 4 | 2013-08-01 | The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart. |
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