Washington University School of Medicine
The goal of this clinical trial is to determine the biodistribution, safety, and calculate the radiation dosimetry of the novel atherosclerotic PET imaging radiotracer, 64Cu-NODAGA-CANF, in normal healthy adult volunteers. Participants will receive a single intravenous administration of 64Cu-NODAGA-CANF and then undergo PET-CT imaging at various time points following injection. Safety will be assessed through evaluation of vital signs, clinical laboratory tests, physical examination, and electrocardiograms (EKGs). Telephone follow-up will occur 2-3 days after discharge.
This study is a single center, open-label baseline controlled imaging study designed to demonstrate safety, biodistribution and dosimetry of the radiopharmaceutical 64Cu-NODAGA-CANF (Cu = copper; CANF = C-type Atrial Natriuretic Factor) in healthy adult volunteers. By definition a "healthy" volunteer is an individual who, by physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease and, by history, is not under the care of a physician for any active medical conditions. Each volunteer will receive a single intravenous bolus injection of less than 4 mCi of the inve…
Inclusion Criteria: * Adults, 18 years of age or older. * Healthy adult normal volunteer subjects (4 males and 4 females). "Healthy adult normal volunteer subject" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease and is not under the care of a physician for any active medical conditions. Exclusion Criteria: * Inability to receive and sign informed consent. * Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the…
Single intravenous (IV) injection of less than 4 mCi of 64Cu-NODAGA-CANF followed by PET-CT imaging at 3 or 4 time points up to 48 hours post-injection (30-60 minutes, 2-6 hours, 18-24 hours and 40-48 hours).
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