An Early Phase 1 interventional study of [18F]4F-MHPG and [18F]3F-PHPG in Autonomic Peripheral Nervous System Diseases, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by University of Michigan · Early Phase 1, Interventional, and Diagnostic
The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac sympathetic nerve imaging agents, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG) and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG).
In this study, PET imaging studies of two structurally related 18F-hydroxyphenethylguanidines, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG) and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) will be performed. All studies will be performed in normal healthy volunteers.
PET stands for Positron Emission Tomography which is a type of imaging that uses a radioactive tracer. This is also called a radiotracer which is a compound linked to a radioactive element. Most compounds are short-lived, meaning that the radioactivity breaks down quickly or is excreted from the body.
In the first stage of the study, dynamic PET imaging for 90 min will be done with [18F]4F-MHPG (n = 4) and [18F]3F-PHPG (n = 4).
Data from these studies will assess each radiotracer's imaging properties, pharmacokinetics and metabolic breakdown in plasma. Application of tracer kinetic analysis methods to the kinetics of each tracer in heart and plasma will be studied to see if these methods can provide accurate measurements of regional nerve sympathetic nerve density in the hearts of human subjects. Results from these initial studies will be used to select the lead compound for further studies in patient populations.
In the second stage of the study, whole-body PET imaging studies (n = 4) with the selected lead radiotracer will be performed to acquire data necessary for generating more accurate human radiation absorbed dose estimates.
168 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 108 interventional studies indexed under Autonomic Nervous System Diseases.
Browse Autonomic Nervous System Diseases studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
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Exclusion Criteria:
Subjects (n = 4) will be injected one time with 6.5 mCi of 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and receive a 90 minute PET scan.
Drug: [18F]4F-MHPG
Subjects (n = 4) will be injected one time with 6.5 mCi of 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) and receive a 90 minute PET scan.
Drug: [18F]3F-PHPG
Subjects (n = 4) will be injected one time with 6.5 mCi of either \[18F\]4F-MHPG or \[18F\]3F-PHPG (whichever is selected based on Protocol 1 studies) and receive four whole-body PET scans, starting at 5 min, 60 min, 150 min and 360 min after tracer injection.
Drug: [18F]4F-MHPG · Drug: [18F]3F-PHPG
IV injection of \[18F\]4F-MHPG
Also known as: 4-[18F]fluoro-meta-hydroxyphenethylguanidine
IV injection of \[18F\]3F-PHPG
Also known as: 3-[18F]fluoro-para-hydroxyphenethylguanidine
Composite measure based on radiotracer tissue uptake ratios (heart-to-lung ratio, heart-to-liver ratio, heart-to-blood ratio) and rates of metabolism in plasma (half-time, in minutes) of [18F]4F-MHPG and [18F]3F-PHPG in healthy subjects.
These data will be used to select the lead radiotracer for further clinical development.
Time frame: 3 months
Radiation Dose
Human radiation absorbed dose estimates based on the kinetics of the selected lead radiotracer in various organs, as extracted from whole-body PET scans.
Time frame: 1 year
Number of Adverse Events
Number of study participants with adverse events as a measure of safety and tolerability following intravenous administration of \[18F\]4F-MHPG or \[18F\]3F-PHPG
Time frame: 30 days
Plan to share: No
Ran from Mar 2015 to primary completion in Aug 2016, 17 months.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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