123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System

Study Overview
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Brief Summary
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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.

Official Title
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123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging

Conditions
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Heart Failure, Cardiomyopathy

Intervention / Treatment
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* Drug: AdreView
* Other: Single Photon Emission Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New York Heart Association Class II or III Heart Failure Left ventricular ejection fraction less than or equal to 35% Exclusion Criteria: Uncompensated heart failure Recent hospitalization within 30 days of cardiac related indications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging<br>SPECT imaging of 10 millicurie of Adreview | Drug: AdreView<br>* 10 millicurie of AdreView (123I-mIBG)<br>Other: Single Photon Emission Computed Tomography<br> <br> * Other names: SPECT;|
| Active Comparator: AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging<br>SPECT imaging of 10 millicurie of Adreview | Drug: AdreView<br>* 10 millicurie of AdreView (123I-mIBG)<br>Other: Single Photon Emission Computed Tomography<br> <br> * Other names: SPECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of H/M ratios obtained on LFOV and SFOV-HE systems | H/M ratios as described will be calculated for the LFOV, and SFOV-HE data sets to determine the correlation between the two measurements. The r value, slope and intercept of this correlation will constitute the primary endpoint of this study. Specifically, we will establish the r value, slope and intercept for: LFOV-Planar vs LFOV-TOMO, LFOV-Planar vs SFOV-HE-TOMO, LFOV-TOMO vs SFOV-HE-TOMO. | 3 months post-enrollment close | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | We will investigate differences between the measurements in the SFOV-HE using the forward projections of the tomographic data and tomographic measurements of the H/M as other methods of establishing the correlation between tomographic and planar measurement of mIBG uptake. | 3 month post-enrollment close | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio