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PET Imaging CCR2 in Lung Inflammation

ConditionLung Inflammation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorWashington University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cu-DOTA-ECL1i

    Drug

    Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Healthy Volunteer GroupExperimental treatment 1 intervention
Group B: ILD Documented Diagnosed Volunteer GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion
2

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.

Time frame
Through study completion
3

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

Time frame
Through study completion

Secondary outcomes

1

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

Time frame
Through study completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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