NCT03492762 PET Imaging CCR2 in Lung Inflammation
| NCT ID | NCT03492762 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Washington University School of Medicine |
| Condition | Lung Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2018-02-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2018-02-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Steven Brody, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03492762 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Lung Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03492762 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03492762 currently recruiting?
Yes, NCT03492762 is actively recruiting participants. Contact the research team at brodys@wustl.edu for enrollment information.
Where is the NCT03492762 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT03492762 clinical trial?
NCT03492762 is sponsored by Washington University School of Medicine. The principal investigator is Steven Brody, MD at Washington University School of Medicine. The trial plans to enroll 110 participants.