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

Phase 4

Completed

• Conditions: Heart Failure; Cardiomyopathy
• Interventions: Drug: AdreView; Other: Single Photon Emission Computed Tomography

• Registration Number: NCT01868841
• Lead Sponsor: Timothy M. Bateman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Study Start: 2013-12
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging	Single Photon Emission Computed Tomography	SPECT imaging of 10 millicurie of Adreview
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging	AdreView	SPECT imaging of 10 millicurie of Adreview
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging	Single Photon Emission Computed Tomography	SPECT imaging of 10 millicurie of Adreview
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging	AdreView	SPECT imaging of 10 millicurie of Adreview

Primary Outcome Measures

Name	Time	Method
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems	3 months post-enrollment close	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.

Secondary Outcome Measures

Name	Time	Method
Image Quality	3 month post-enrollment close	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.

Trial Locations

Locations (1)

Cardiovascular Imaging Technologies; 🇺🇸 Kansas City, Missouri, United States