Assessing lung inflammation using PET imaging
PET Imaging CCR2 in Lung Inflammation
EARLY_PHASE1 · Washington University School of Medicine · NCT03492762
This study is testing a new imaging tool to see if it can help track inflammation in the lungs of people with fibrotic lung diseases.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT03492762 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the distribution of a PET imaging radiotracer, Cu-DOTA-ECL1i, in patients with fibrotic lung diseases. The study will involve 60 patients with interstitial lung disease (ILD) and 5 healthy volunteers as controls, all undergoing dynamic PET/CT scans to characterize the uptake of the radiotracer in the lungs. Additionally, sub-studies will assess the reproducibility of the scans and the correlation between imaging results and inflammatory cell distribution in lung tissue. The overall goal is to determine the potential of this radiotracer to track inflammatory cells in lung diseases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with a history of smoking and diagnosed with fibrotic lung diseases.
Not a fit: Patients with significant comorbidities affecting lung function or those currently enrolled in other conflicting studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a new imaging tool to better understand and monitor lung inflammation in patients with fibrotic lung diseases.
How similar studies have performed: While this approach is innovative, similar studies using PET imaging for tracking inflammation have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Steven Brody, MD — Washington University School of Medicine
- Study coordinator: Steven Brody, MD
- Email: brodys@wustl.edu
- Phone: 314-362-8969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Inflammation