PET Imaging CCR2 in Lung Inflammation
ConditionLung Inflammation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cu-DOTA-ECL1i
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov