Trial Outcomes & Findings for Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView. (NCT NCT01936649)
NCT ID: NCT01936649
Last Updated: 2016-12-08
Results Overview
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.
COMPLETED
PHASE4
63 participants
3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days
2016-12-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
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63
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Overall Study
Treated
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51
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Overall Study
COMPLETED
|
50
|
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Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
4
|
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Overall Study
Physician Decision
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2
|
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Overall Study
Protocol Violation
|
2
|
|
Overall Study
Other than specified above
|
5
|
Baseline Characteristics
Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.
Baseline characteristics by cohort
| Measure |
AdreView (Iobenguane I 123 Injection)
n=51 Participants
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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Age, Continuous
|
65.2 years
STANDARD_DEVIATION 12.46 • n=93 Participants
|
|
Sex: Female, Male
Female
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8 Participants
n=93 Participants
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Sex: Female, Male
Male
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43 Participants
n=93 Participants
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|
Region of Enrollment
United States
|
51 participants
n=93 Participants
|
|
Safety Assessment
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51 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
AdreView (Iobenguane I 123 Injection)
n=47 Participants
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.
|
|---|---|
|
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)
Technologist A (post dosing-1) (n=46)
|
1.435 Ratio
Standard Deviation 0.2238
|
|
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)
Technologist A (post dosing-2) (n=47)
|
1.422 Ratio
Standard Deviation 0.2229
|
|
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)
Technologist A(Dosings:absolute difference) (n=46)
|
0.070 Ratio
Standard Deviation 0.0612
|
|
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)
Technologist B (post dosing-1) (n=47)
|
1.430 Ratio
Standard Deviation 0.220
|
|
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)
Technologist B (post dosing-2) (n=47)
|
1.436 Ratio
Standard Deviation 0.2069
|
|
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)
Technologist B(Dosings:absolute difference) (n=47)
|
0.060 Ratio
Standard Deviation 0.0413
|
|
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)
Technologist C (post dosing-1) (n=47)
|
1.427 Ratio
Standard Deviation 0.2115
|
|
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)
Technologist C (post dosing-2) (n=47)
|
1.441 Ratio
Standard Deviation 0.1945
|
|
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)
Technologist C(Dosings:absolute difference) (n=47)
|
0.067 Ratio
Standard Deviation 0.0537
|
|
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)
Average (post dosing-1) (n=47)
|
1.429 Ratio
Standard Deviation 0.2160
|
|
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)
Average (post dosing-2) (n=47)
|
1.433 Ratio
Standard Deviation 0.2048
|
|
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)
Average (Dosings:absolute difference) (n=47)
|
0.065 Ratio
Standard Deviation 0.0348
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SECONDARY outcome
Timeframe: 15 minutes post administration of 2 dosing within an interval of 5 to 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
AdreView (Iobenguane I 123 Injection)
n=47 Participants
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.
|
|---|---|
|
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)
Technologist A (post dosing-1) (n=47)
|
1.584 Ratio
Standard Deviation 0.2258
|
|
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)
Technologist A (post dosing-2) (n=47)
|
1.567 Ratio
Standard Deviation 0.2267
|
|
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)
Technologist A(Dosings:absolute difference) (n=47)
|
0.081 Ratio
Standard Deviation 0.0765
|
|
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)
Technologist B (post dosing-1) (n=47)
|
1.568 Ratio
Standard Deviation 0.2262
|
|
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)
Technologist B (post dosing-2) (n=47)
|
1.553 Ratio
Standard Deviation 0.2169
|
|
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)
Technologist B(Dosings:absolute difference) (n=47)
|
0.062 Ratio
Standard Deviation 0.0532
|
|
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)
Technologist C (post dosing-1) (n=47)
|
1.593 Ratio
Standard Deviation 0.2227
|
|
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)
Technologist C (post dosing-2) (n=47)
|
1.571 Ratio
Standard Deviation 0.2203
|
|
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)
Technologist C(Dosing:absolute difference) (n=47)
|
0.071 Ratio
Standard Deviation 0.0541
|
|
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)
Average (post dosing-1) (n=47)
|
1.581 Ratio
Standard Deviation 0.2212
|
|
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)
Average (post dosing-2) (n=47)
|
1.564 Ratio
Standard Deviation 0.2195
|
|
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)
Average (Dosings:absolute difference) (n=47)
|
0.072 Ratio
Standard Deviation 0.0485
|
Adverse Events
AdreView (Iobenguane I 123 Injection)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER