Type 2 Diabetes Clinical Trial
Official title:
A Preliminary Evaluation of the Safety and Pancreas Imaging Properties of 18F-AV-133 in Healthy Volunteers and in Patients With Type 1 or Type 2 Diabetes
The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.
The primary objective of this protocol is to address the feasibility for further development
of the VMAT2-binding compound 18F-AV-133 as a diagnostic radiopharmaceutical in the field of
diabetes. Specifically, this study will evaluate 18F-AV-133 imaging in patients with type 1
diabetes, patients with type 2 diabetes and in healthy controls in order to:
1. Obtain information regarding the safety of 18F-AV-133 in these populations;
2. Determine whether uptake, distribution, or clearance of 18F-AV-133 in the pancreas
differs between subjects with predicted reduced beta cell mass (patients with type 1 or
type 2 diabetes of long duration) and normal beta cell mass (healthy volunteers);
3. Evaluate the PET imaging pharmacokinetics of 18F-AV-133 in abdominal organs of healthy
control subjects and patients with type 1 or type 2 diabetes;
4. Obtain preliminary information regarding the appropriate time window for optimal PET
imaging of 18F-AV-133 in the pancreas post-administration for type 1, type 2, and normal
healthy individuals;
5. Obtain preliminary information regarding an appropriate reference tissue for evaluating
the PET imaging results of 18F-AV-133 in the pancreas; and
6. Evaluate the imaging properties of 18F-AV-133 in the pancreas relative to the brain in a
subset of subjects.
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