Back to results123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
Primary Purpose
Heart Failure, Cardiomyopathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AdreView
Single Photon Emission Computed Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring 123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio
Eligibility 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
Sites / Locations
- Cardiovascular Imaging Technologies
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging
Arm Description
SPECT imaging of 10 millicurie of Adreview
SPECT imaging of 10 millicurie of Adreview
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01868841
First Posted
May 14, 2013
Last Updated
January 9, 2018
Sponsor
Timothy M. Bateman
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01868841
Brief Title
123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
Official Title
123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy M. Bateman
Collaborators
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiomyopathy
Keywords
123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging
Arm Type
Active Comparator
Arm Description
SPECT imaging of 10 millicurie of Adreview
Arm Title
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging
Arm Type
Active Comparator
Arm Description
SPECT imaging of 10 millicurie of Adreview
Intervention Type
Drug
Intervention Name(s)
AdreView
Intervention Description
10 millicurie of AdreView (123I-mIBG)
Intervention Type
Other
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
SPECT
Primary Outcome Measure Information:
Title
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
Description
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.
Time Frame
3 months post-enrollment close
Secondary Outcome Measure Information:
Title
Image Quality
Description
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.
Time Frame
3 month post-enrollment close
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Bateman, MD
Organizational Affiliation
Aspire Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Imaging Technologies
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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