CClinicalTrials.gg
CompletedNCT01936649Updated Dec 8, 2016Results posted

Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.

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

Phase
Phase 4
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Heart Failure (HF)
  • Ventricular Dysfunction, Left

Keywords

  • Nuclear imaging
  • Radiopharmaceutical
  • Iobenguane
  • I-123
  • reproducibility
  • Quantitative measurements
  • myocardial uptake
  • SPECT imaging
  • planar imaging
  • AdreView™
03

In context

Ventricular Dysfunction

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The participant was originally diagnosed with New York Heart Association (NYHA) Class II-III HF due to ischemic heart disease at least 3 months or due to non-ischemic cardiomyopathy at least 6 months before enrollment into the study.
  • The participant had Left Ventricular (LV) dysfunction with Left Ventricular Ejection Fraction (LVEF) less than or equal to 35% measured by an appropriate method (e.g., radionuclide or contrast ventriculography, electrocardiogram [ECG]-gated SPECT myocardial perfusion imaging [MPI], magnetic resonance [MR] imaging, computed tomography [CT] or echocardiography) within 6 months of enrollment into the study and documented in the participant's medical record.
  • The participant had a history of compliance with prescribed heart failure (HF) medications and took HF guidelines-based medication at study entry including at a minimum a beta-blocker and either an angiotensin converting enzyme inhibitor or angiotensin receptor antagonist unless documented to be intolerant to any of these classes of medications.
  • The participant had been on a stable medical regimen for a minimum of 3 months, with no hospitalizations or change in HF medications or HF symptoms.
  • Participants must be clinically stable for at least 7 days before enrolling into the study (e.g., not experiencing continuing chest pain or hemodynamic instability).

Exclusion criteria

Exclusion Criteria:

  • The participant had previously received 123 I-mIBG or 131 I-mIBG.
  • The participant had known or suspected hypersensitivity/allergy to iodine, Iobenguane or to any of the excipients in AdreView.
  • The participant had a heart transplant at any time prior to enrollment.
  • The participant had LVEF >35% as measured by an appropriate method (e.g., radionuclide or contrast ventriculography, ECG-gated SPECT MPI, MR, CT, or echocardiography) within 30 days prior to enrollment into the study.
  • The participant had received defibrillation either external or via an implantable cardioverter defibrillator (ICD), anti-tachycardia pacing, or cardioversion to treat an arrhythmic event in the previous 90 days.
  • The participant had a cardiac revascularization, insertion of an ICD, or acute myocardial infarction within 30 days before study entry.
  • The participant used any of the following medications: Amitriptyline and derivatives, imipramine and derivatives, other antidepressants that inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines and cocaine.
  • The participant had either NYHA Class I or NYHA Class IV HF at the time of study entry.
  • The participant had renal insufficiency (creatinine >3 mg/dl).
  • The participant had participated in a clinical trial involving IMP or devices within 30 days prior to first administration of AdreView™.
  • In the investigator's opinion, the participant's medical history included either extensive lifetime exposure to ionizing radiation (medical, occupational, other) or documented total radiation dose >50 mSv during the previous 5 years.
  • The participant had experienced HF hospitalization, increased HF symptoms without hospitalization, or had a change or increase in HF medications during the previous 3 months.
  • The participant had a serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    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.

    Drug: AdreView (Iobenguane I 123 Injection)

Interventions

  • DrugAdreView (Iobenguane I 123 Injection)

    AdreView 10 mCi as a single i.v administration

    Also known as: meta-iodobenzylguanidine (123 I-mIBG)

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Jan 26, 2015

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.

Participant flow — Overall Study
MilestoneAdreView (Iobenguane I 123 Injection)
Started63
Treated51
Completed50
Not completed13
Withdrew: Withdrawal by subject4
Withdrew: Physician decision2
Withdrew: Protocol violation2
Withdrew: Other than specified above5

Outcome measures

PrimaryTo 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
Reported as:
Mean · Ratio
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)
RatioAdreView (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
SecondaryTo 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
Reported as:
Mean · Ratio
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)
RatioAdreView (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

Adverse events

Collected over From Baseline up to discharge from hospital on each dosing.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AdreView (Iobenguane I 123 Injection)—0/51 (0%)0/51 (0%)

Baseline characteristics

Safety population defined as all enrolled participants who received at least 1 administration of AdreView (Iobenguane I 123 Injection).

Age, Continuous
Age, Continuous(years)AdreView (Iobenguane I 123 Injection)
Mean65.2 ± 12.46
Sex: Female, Male
Sex: Female, Male(Participants)AdreView (Iobenguane I 123 Injection)
Female8
Male43
Region of Enrollment
Region of Enrollment(participants)AdreView (Iobenguane I 123 Injection)
United States51
Safety Assessment
Safety Assessment(participants)AdreView (Iobenguane I 123 Injection)
Number51
08

Study locations

1 site
  • GE Healthcare
    Princeton, New Jersey 08540, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01936649
Lead sponsor
GE Healthcare
Collaborators
H2O Clinical LLC, Quintiles, Inc.
Responsible party
Sponsor
First posted
Sep 6, 2013
Start date
Aug 2013
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
Jan 26, 2015
Last update
Dec 8, 2016

Study contacts

Arnold Jacobson, M.D.
study chair · GE Healthcare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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