NCT01936649

Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.

A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView (Iobenguane I 123 Injection)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart.

Conditions

• Heart Failure (HF)
• Ventricular Dysfunction, Left

Interventions

Type	Name	Description
DRUG	AdreView (Iobenguane I 123 Injection)	AdreView 10 mCi as a single i.v administration

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-09-06
• Last updated: 2016-12-08
• Results posted: 2015-01-26

Locations

1 site across 1 country: United States