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

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ClinicalTrials.gov Identifier: NCT01868841
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Timothy M. Bateman, Aspire Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiomyopathy Drug: AdreView Other: Single Photon Emission Computed Tomography Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
Study Start Date : December 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: SPECT


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868841


Locations
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United States, Missouri
Cardiovascular Imaging Technologies
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Timothy M. Bateman
GE Healthcare
Investigators
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Principal Investigator: Timothy M Bateman, MD Aspire Foundation
More Information
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Responsible Party: Timothy M. Bateman, Medical Director, Aspire Foundation
ClinicalTrials.gov Identifier: NCT01868841    
Other Study ID Numbers: 13-039
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Keywords provided by Timothy M. Bateman, Aspire Foundation:
123I-mIBG
AdreView
SPECT
Heart to Mediastinal Ratio
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases