PET Imaging CCR2 in Lung Inflammation

Lung Inflammation Clinical Trial

Official title:

PET Imaging CCR2 in Lung Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03492762
• Other study ID #: 20171192
• Secondary ID: R01HL151685-01A1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 27, 2018
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2022
• Source: Washington University School of Medicine
• Contact: Steven Brody, MD
• Phone: 314-362-8969
• Email: brodys[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Lung Inflammation
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of uptake of Cu-DOTA-ECL1i to lung fibrosis	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	Through study completion
Primary	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	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.	Through study completion
Primary	Determine rate of kinetics of Cu-DOTA-ECL1i	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	Through study completion
Secondary	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	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 using pulmonary function measures	Through study completion