drugset / Trial / NCT02669563

An Exploratory Study of 18F-Labeled Hydroxyphenethylguanidines in Heart Failure Patients

NCT02669563

Phase 0 Completed 16 enrolled University of Michigan
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

The main goal of this study is to test two new radioactive drugs, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) in human subjects with congestive heart failure. Evaluations of these imaging agents will include their uptake in heart, lungs and liver, their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies, the better of the two drugs will be chosen for further studies in patients with heart disease. After the better compound is chosen, additional measures of its imaging properties, metabolism and pharmacokinetics will be done in subjects with heart failure.

Timeline

Start
2015-12
Primary completion
2016-08
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject N-13 ammonia Diagnostic / imaging agent 20 unknown Intravenous
Subject [11C]HED Diagnostic / imaging agent 20 unknown Intravenous
Subject [18F]3F-PHPG Unknown 6.5 unknown Intravenous
Subject [18F]4F-MHPG Unknown 6.5 unknown Intravenous

Indications