Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | December 2017 |
| Contact: | David M Raffel, PhD |
| Email: | raffel@umich.edu |
| Phone: | 734 763-9244 |
Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines for Quantification of Regional Cardiac Sympathetic Nerve Density With PET
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).
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.
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.
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.
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.
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
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