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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01868841

Enrollment

Registered

2013-06-05

Start date

2013-12-31

Completion date

2014-10-31

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Heart Failure

Keywords

123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio

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.

Interventions

DRUGAdreView

10 millicurie of AdreView (123I-mIBG)

OTHERSingle Photon Emission Computed Tomography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems	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

Measure	Time frame	Description
Image Quality	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026