The primary objective of this study is to assess the lung distribution of the Positron Emission Tomography (PET) imaging radiotracer Cu-DOTA-ECL1i, which binds to the specific population inflammatory cells, in patients with fibrotic lung diseases. This objective includes sub-studies to assess radiotracer distribution in the lung, the reproducibility of PET scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue. The overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases.

This is a single site, pilot Phase 0/1 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease (n=60). Healthy volunteers without known pulmonary disease will be recruited as controls (N=5). All subjects will be recruited and undergo one dynamic PET/CT scan to characterize the lung uptake of Cu-DOTA-ECL1i. Among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second PET/CT within two months. A third subgroup of subjects (n=10) who undergo lung transplant will have analysis of CCR2+ cells in their explanted lungs.

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

DE-identified individual participant data for all primary and secondary outcome measures will be made available upon publication of trial results.

Data will be available within 1 year of the study completion.

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.