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Completed

NCT Number: NCT01868841

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

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.

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Key information

Conditions

Heart Failure Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Imaging Technologies

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AdreView

Drug

10 millicurie of AdreView (123I-mIBG)

Single Photon Emission Computed Tomography

Other

Other names: SPECT

Primary outcomes

  1. Relationship of H/M ratios obtained on LFOV and SFOV-HE systems

    Time frame: 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 outcomes

  1. Image Quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Timothy M. Bateman

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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