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| Name | Class |
|---|---|
| H2O Clinical LLC | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdreView (Iobenguane I 123 Injection) | Experimental | Two administrations of single intravenous (i.v) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdreView (Iobenguane I 123 Injection) | Drug | AdreView 10 mCi as a single i.v administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection) | Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability. | 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection) | Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold Jacobson, M.D. | GE Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
Out of 63 enrolled participants, 51 received at least 1 administration of AdreView (Iobenguane I 123 injection) and 50 participants received 2 administrations of AdreView. Myocardial AdreView uptake over time was quantitatively measured via planar and single photon emission computed tomography (SPECT) imaging at various time points post-injection.
The study was conducted at 10 centers in US. A total of 63 participants were enrolled in the study between 16 August 2013 and 20 February 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | AdreView (Iobenguane I 123 Injection) | Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population defined as all enrolled participants who received at least 1 administration of AdreView (Iobenguane I 123 Injection).
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| ID | Title | Description |
|---|---|---|
| BG000 | AdreView (Iobenguane I 123 Injection) | Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection) | Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability. | Efficacy population that included all participants who underwent 2 administrations of AdreView (Iobenguane I 123 Injection); had at least an interpretable planar image acquisition at 3 hours 50 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist. | Posted | Mean | Standard Deviation | Ratio | 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days |
|
From Baseline up to discharge from hospital on each dosing.
Adverse events (AEs) reported were treatment emergent adverse events (TEAEs) that were AEs that begins (or a pre-existing AE that worsens) after receiving investigational medicinal product through the time of discharge on each dosing day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AdreView (Iobenguane I 123 Injection) | Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose Zubeldia | GE Healthcare | 011-44-1494-543137 | jose.zubeldia@ge.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| ID | Term |
|---|---|
| D019797 | 3-Iodobenzylguanidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007462 | Iodobenzenes |
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| 15 minutes post administration of 2 dosing within an interval of 5 to 14 days |
| Other than specified above |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Safety Assessment | Number | participants |
|
| Description |
|---|
| OG000 | AdreView (Iobenguane I 123 Injection) | Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
|
|
| Secondary | To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection) | Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant. | Efficacy population that included all participants who underwent 2 administrations of AdreView; had at least an interpretable planar image acquisition at 15 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist. | Posted | Mean | Standard Deviation | Ratio | 15 minutes post administration of 2 dosing within an interval of 5 to 14 days |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |
|
| Technologist B (post dosing-1) (n=47) |
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| Technologist B (post dosing-2) (n=47) |
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| Technologist B(Dosings:absolute difference) (n=47) |
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| Technologist C (post dosing-1) (n=47) |
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| Technologist C (post dosing-2) (n=47) |
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| Technologist C(Dosing:absolute difference) (n=47) |
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| Average (post dosing-1) (n=47) |
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| Average (post dosing-2) (n=47) |
|
| Average (Dosings:absolute difference) (n=47) |
|