PET Imaging CCR2 in Lung Inflammation

This is a single site, pilot Phase 0/1 clinical trial to establish initial estimates of the
human radiation dosimetry of 64Cu-DOTA-ECL1i. Healthy volunteers and participants who
currently smoke cigarettes but do not have known pulmonary disease will be recruited. Twelve
participants (N=6 healthy, N=6 current smokers) will undergo whole-body PET/CT and PET/MR
imaging at multiple time points after 64Cu-DOTA-ECL1i injection to determine the human
dosimetry for this tracer.

Inclusion Criteria:

- Men or women 21 years of age or older who have never smoked or current smokers who
smoked at least 10 cigarettes per day (1/2 pack) and have smoked at least 100
cigarettes (5 packs) over the past month.

- Screening FEV1 and FVC > 80% of predicted

- Capable of lying still and supine within the PET/CT and PET/MR scanner for ~1 hour and
follow instructions for breathing protocol during the CT portion

- No illicit drug use or other inhaled drug use (including pharmacologic agents,
recreational agents, or illicit drugs) within the past year

- No known history of cardiac, pulmonary, hepatic or renal disease or diabetes

- No history of claustrophobia or other preventing condition that has previously or
would interfere with completion of protocol specified imaging sessions

- Able to comprehend and willing to follow instructions for the study procedures as
called for by the protocol

- BMI ≤ 35

Exclusion Criteria:

- Currently enrolled in another study using an investigational drug

- Pregnancy (confirmed by urine pregnancy test)

- Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes

- Currently taking any prescription medications

- Presence of an implanted device that is incompatible with CT or MRI scanning

- Creatinine > 1.30 mg/dL, AST > 50 Units/L, ALT > 55 Units/L, or total bilirubin > 1.2
mg/dL