NCT03492762 · Washington University School of Medicine
PET Imaging CCR2 in Lung Inflammation
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Cu-DOTA-ECL1i
Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.
Primary outcome measures
Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
Time frame: Through study completion
To establish the relation of lung uptake of Cu-DOTA-ECL1i compared to fibrosis determined by high resolution chest Computed tomography (CT) scan and clinical status
Change of Cu-DOTA-ECL1i as measured by Positron emission tomography (PET) imaging of lung Standard uptake value (SUV) and Distribution Volume Ratio (DVR) over two months
Time frame: Through study completion
Determine reproducibility of Cu-DOTA-ECL1i as measured by Positron emission tomography (PET) imaging of lung Standard uptake value (SUV) and Distribution Volume Ratio (DVR) over two months.
Determine rate of kinetics of Cu-DOTA-ECL1i
Time frame: Through study completion
Determine rate of kinetics of Cu-DOTA-ECL1i in circulation of blood at 0-60 min post-injection of Cu-DOTA-ECL1i by analysis of the arterial blood metabolites compared to lung uptake by Positron emission tomography/Computed tomography (PET/CT) imaging
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
Where
- St Louis, Missouri
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations