A Phase 4 interventional study of AdreView (Iobenguane I 123 Injection) in Heart Failure (HF) and Ventricular Dysfunction, Left, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by GE Healthcare · Phase 4, Interventional, and Diagnostic
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.
262 studies on the registry are indexed under Ventricular Dysfunction; 40 are open to participants now.
This study's enrollment of 63 is close to the median of 63 across 144 interventional studies indexed under Ventricular Dysfunction.
Browse Ventricular Dysfunction studies →GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
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Exclusion Criteria:
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.
Drug: AdreView (Iobenguane I 123 Injection)
AdreView 10 mCi as a single i.v administration
Also known as: meta-iodobenzylguanidine (123 I-mIBG)
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.
Time frame: 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days
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.
Time frame: 15 minutes post administration of 2 dosing within an interval of 5 to 14 days
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.
| Milestone | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Started | 63 |
| Treated | 51 |
| Completed | 50 |
| Not completed | 13 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Physician decision | 2 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Other than specified above | 5 |
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.
| Ratio | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Technologist A (post dosing-1) (n=46) | 1.435 ± 0.2238 |
| Technologist A (post dosing-2) (n=47) | 1.422 ± 0.2229 |
| Technologist A(Dosings:absolute difference) (n=46) | 0.070 ± 0.0612 |
| Technologist B (post dosing-1) (n=47) | 1.430 ± 0.220 |
| Technologist B (post dosing-2) (n=47) | 1.436 ± 0.2069 |
| Technologist B(Dosings:absolute difference) (n=47) | 0.060 ± 0.0413 |
| Technologist C (post dosing-1) (n=47) | 1.427 ± 0.2115 |
| Technologist C (post dosing-2) (n=47) | 1.441 ± 0.1945 |
| Technologist C(Dosings:absolute difference) (n=47) | 0.067 ± 0.0537 |
| Average (post dosing-1) (n=47) | 1.429 ± 0.2160 |
| Average (post dosing-2) (n=47) | 1.433 ± 0.2048 |
| Average (Dosings:absolute difference) (n=47) | 0.065 ± 0.0348 |
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.
| Ratio | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Technologist A (post dosing-1) (n=47) | 1.584 ± 0.2258 |
| Technologist A (post dosing-2) (n=47) | 1.567 ± 0.2267 |
| Technologist A(Dosings:absolute difference) (n=47) | 0.081 ± 0.0765 |
| Technologist B (post dosing-1) (n=47) | 1.568 ± 0.2262 |
| Technologist B (post dosing-2) (n=47) | 1.553 ± 0.2169 |
| Technologist B(Dosings:absolute difference) (n=47) | 0.062 ± 0.0532 |
| Technologist C (post dosing-1) (n=47) | 1.593 ± 0.2227 |
| Technologist C (post dosing-2) (n=47) | 1.571 ± 0.2203 |
| Technologist C(Dosing:absolute difference) (n=47) | 0.071 ± 0.0541 |
| Average (post dosing-1) (n=47) | 1.581 ± 0.2212 |
| Average (post dosing-2) (n=47) | 1.564 ± 0.2195 |
| Average (Dosings:absolute difference) (n=47) | 0.072 ± 0.0485 |
Collected over From Baseline up to discharge from hospital on each dosing.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AdreView (Iobenguane I 123 Injection) | — | 0/51 (0%) | 0/51 (0%) |
Safety population defined as all enrolled participants who received at least 1 administration of AdreView (Iobenguane I 123 Injection).
| Age, Continuous(years) | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Mean | 65.2 ± 12.46 |
| Sex: Female, Male(Participants) | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Female | 8 |
| Male | 43 |
| Region of Enrollment(participants) | AdreView (Iobenguane I 123 Injection) |
|---|---|
| United States | 51 |
| Safety Assessment(participants) | AdreView (Iobenguane I 123 Injection) |
|---|---|
| Number | 51 |
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