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.
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.
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 study.
Inability to tolerate up to 60 minutes in a supine position with arms above head for PET-CT.
Normal adult volunteer subjects with evidence of disease based on clinical evaluation and/or blood laboratory tests, which are judged by the Sponsor-Investigator or designee to interfere with the objectives of the protocol.
Single group
64Cu-NODAGA-CANF
DrugSingle 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).
Organ radiation dose of 64Cu-NODAGA-CANF
Tracer biodistribution will be evaluated by measuring uptake of 64Cu-NODAGA-CANF in various organs as determined by PET-CT imaging. The organs used to describe the biodistribution of the radiopharmaceutical will be blood, liver, kidneys, spleen, heart, marrow, and muscle as appropriate as seen as organs showing significant uptake. Only organs and tissues containing a visible accumulation of activity will be selected for image quantification. Regions of Interest (ROIs) will be drawn to measure average activity concentration in each organ or tissue. Time activity curves will be then constructed from these values. Time Integrated Activity (formerly known as residence times) will be calculated by analytical or numerical integration of the fitted time taking into account the radioactive decay of 64Cu. Dose calculations will be performed using MIRDCalc software for either the adult male or adult female model as appropriate for each patient using the calculated Time Integrated Activity.
Effective Dose of 64Cu-NODAGA-CANF
Effective dose of 64Cu-NODAGA-CANF calculated by analysis of biodistribution of 64Cu-NODAGA-CANF from PET-CT images. Dose calculations will be performed using MIRDCalc software for either the adult male or adult female model as appropriate for each patient using the calculated Time Integrated Activity (residence times).
Number of participants with treatment-related adverse events
Subjects will be monitored for adverse events from the time of consent through follow-up. Follow-up will occur by telephone 2-3 days after discharge. Adverse events are defined as any untoward medical occurrence in a subject who receives 64Cu-NODAGA-CANF, including any unfavorable or unintended sign, symptom, or disease temporally associated with the injection of 64Cu-NODAGA-CANF. Treatment-related means there is a reasonable possibility that the incident, experience, or outcome was or may have been caused by the treatment.
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Washington University School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
