PET Imaging CCR2 in Lung Inflammation

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine the safety of the novel probe 64Cu-DOTA-ECL1i for PET imaging of CCR2 expression.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine

Criteria

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