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

NCT ID: NCT01868841

Last Updated: 2018-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging

SPECT imaging of 10 millicurie of Adreview

Group Type ACTIVE_COMPARATOR

AdreView

Intervention Type DRUG

10 millicurie of AdreView (123I-mIBG)

Single Photon Emission Computed Tomography

Intervention Type OTHER

AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging

SPECT imaging of 10 millicurie of Adreview

Group Type ACTIVE_COMPARATOR

AdreView

Intervention Type DRUG

10 millicurie of AdreView (123I-mIBG)

Single Photon Emission Computed Tomography

Intervention Type OTHER

Interventions

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AdreView

10 millicurie of AdreView (123I-mIBG)

Intervention Type DRUG

Single Photon Emission Computed Tomography

Intervention Type OTHER

Other Intervention Names

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SPECT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Timothy M. Bateman

OTHER

Sponsor Role lead

Responsible Party

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Timothy M. Bateman

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Timothy M Bateman, MD

Role: PRINCIPAL_INVESTIGATOR

Aspire Foundation

Locations

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Cardiovascular Imaging Technologies

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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13-039

Identifier Type: -

Identifier Source: org_study_id

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