PET Imaging CCR2 in Lung Inflammation

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