Clinical trial NCT03492762: PET Imaging CCR2 in Lung Inflammation
Official title: PET Imaging CCR2 in Lung Inflammation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Lung Inflammation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-04-10
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: Healthy Volunteers and Volunteers with Documented ILD Diagnosis
Primary purpose: DIAGNOSTIC

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.

Detailed description: This is a single site, pilot Phase 0/1 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease (n=60). Healthy volunteers without known pulmonary disease will be recruited as controls (N=5). All subjects will be recruited and undergo one dynamic PET/CT scan to characterize the lung uptake of Cu-DOTA-ECL1i. Among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second PET/CT within two months. A third subgroup of subjects (n=10) who undergo lung transplant will have analysis of CCR2+ cells in their explanted lungs.

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

Primary outcomes:
measure: Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
timeFrame: Through study completion
measure: 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
timeFrame: Through study completion
measure: Determine rate of kinetics of Cu-DOTA-ECL1i
timeFrame: Through study completion
Secondary outcomes:
measure: Determine relationship between Cu-DOTA-ECL1i lung tissue as seen by Positron emission tomography (PET) imaging and lung tissue showing C-C Motif Chemokine Receptor 2 (CCR2+) cells
timeFrame: Through study completion
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Steven Brody, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brody SL, Gunsten SP, Luehmann HP, Sultan DH, Hoelscher M, Heo GS, Pan J, Koenitzer JR, Lee EC, Huang T, Mpoy C, Guo S, Laforest R, Salter A, Russell TD, Shifren A, Combadiere C, Lavine KJ, Kreisel D, Humphreys BD, Rogers BE, Gierada DS, Byers DE, Gropler RJ, Chen DL, Atkinson JJ, Liu Y. Chemokine Receptor 2-targeted Molecular Imaging in Pulmonary Fibrosis. A Clinical Trial. Am J Respir Crit Care Med. 2021 Jan 1;203(1):78-89. doi: 10.1164/rccm.202004-1132OC.