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

Timothy M. Bateman

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy; Heart Failure

Treatments: Other: Single Photon Emission Computed Tomography; Drug: AdreView

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01868841

13-039

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging

Active Comparator group

Description:

SPECT imaging of 10 millicurie of Adreview

Treatment:

Drug: AdreView

Other: Single Photon Emission Computed Tomography

AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging

Active Comparator group

Description:

SPECT imaging of 10 millicurie of Adreview

Treatment:

Drug: AdreView

Other: Single Photon Emission Computed Tomography