123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 heart-failure
Started Dec 2013
Shorter than P25 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJanuary 11, 2018
January 1, 2018
9 months
May 14, 2013
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Image Quality
3 month post-enrollment close
Study Arms (2)
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging
ACTIVE COMPARATORSPECT imaging of 10 millicurie of Adreview
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging
ACTIVE COMPARATORSPECT imaging of 10 millicurie of Adreview
Interventions
10 millicurie of AdreView (123I-mIBG)
Eligibility Criteria
You may qualify if:
- New York Heart Association Class II or III Heart Failure
- Left ventricular ejection fraction less than or equal to 35%
You may not qualify if:
- Uncompensated heart failure
- Recent hospitalization within 30 days of cardiac related indications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Timothy M. Batemanlead
- GE Healthcarecollaborator
Study Sites (1)
Cardiovascular Imaging Technologies
Kansas City, Missouri, 64111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy M Bateman, MD
Aspire Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
May 14, 2013
First Posted
June 5, 2013
Study Start
December 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
January 11, 2018
Record last verified: 2018-01