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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868841
• Other study ID #: 13-039
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2013
• Last updated: January 9, 2018
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2018
• Source: Aspire Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

Intervention

Drug:
• AdreView
10 millicurie of AdreView (123I-mIBG)

Other:
• Single Photon Emission Computed Tomography

Locations

Country	Name	City	State
United States	Cardiovascular Imaging Technologies	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Timothy M. Bateman	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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