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

NCT01936649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-12-08

Study results available
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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

DRUG

AdreView (Iobenguane I 123 Injection)

AdreView 10 mCi as a single i.v administration

Sponsors & Collaborators

  • H2O Clinical LLC

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Arnold Jacobson, M.D. · GE Healthcare

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936649 on ClinicalTrials.gov