Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines
This trial is active, not recruiting.
|Condition||autonomic peripheral nervous system diseases|
|Sponsor||University of Michigan|
|Start date||March 2015|
|End date||October 2016|
|Trial size||16 participants|
|Trial identifier||NCT02385877, HUM00088601|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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.
time frame: 3 months
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 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: up to 30 days after [18F]4F-MHPG or [18F]3F-PHPG injection
Male or female participants from 18 years up to 55 years old.
Inclusion Criteria: - Non-obese (BMI < 30) - Normal blood pressure - Normal blood lipid profile - No history of prior cardiovascular disease - Not susceptible to claustrophobia - Ability to lay flat for 90 min Exclusion Criteria: - Obesity (BMI > 30) - Risk factors for heart disease (age > 55y, hypertension, smoking, high blood pressure, high cholesterol levels, diabetes, etc.) - History of heart disease (heart attack, atrial fibrillation, ventricular tachycardia, exertional angina) - Currently using certain medications that may interact with cardiac nerves (antidepressants, cold medications, nasal decongestants, monoamine oxidase inhibitors, etc.) - Claustrophobia - Inability to lie flat for 90 min - Pregnant or breast feeding
|Official title||Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines for Quantification of Regional Cardiac Sympathetic Nerve Density With PET|
|Principal investigator||David M Raffel, PhD|
|Description||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.|
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