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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiomyopathy
• Intervention / Treatment: Drug: AdreView; Other: Single Photon Emission Computed Tomography

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Cardiovascular Imaging Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Timothy M. Bateman
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Timothy M Bateman, MD, Aspire Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: SPECT; 123I-mIBG; AdreView; Heart to Mediastinal Ratio
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 13-039