Lung InflammationEarly Phase 1NCT03492762
PET Imaging CCR2 in Lung Inflammation
A Early Phase 1 study testing Cu-DOTA-ECL1i in people with Lung Inflammation, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Inflammation
- What is being tested?
- Cu-DOTA-ECL1i
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Steven Brody, MD, 314-362-8969, brodys@wustl.edu
About this study
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.
Read the 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.
- Conditions
- Lung Inflammation
- Being tested
- Cu-DOTA-ECL1i
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu-DOTA-ECL1iDrug
Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer Group | Experimental | The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group Receives: Drug: Cu-DOTA-ECL1i |
| ILD Documented Diagnosed Volunteer Group | Experimental | The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group Receives: Drug: Cu-DOTA-ECL1i |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion
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.
Measured: Through study completion
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
Measured: 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
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start27 Feb 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung InflammationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: Healthy Volunteers and Volunteers with Documented ILD Diagnosis
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Steven Brody, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492762
- Sponsor's protocol ID
- 20171192
- Other IDs
- R01HL151685-01A1
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2018
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: DE-identified individual participant data for all primary and secondary outcome measures will be made available upon publication of trial results.
Publications
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.
PubMed 32673071
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging CCR2 in Lung Inflammation
- ClinicalTrials.gov ID
- NCT03492762
- Acronym / sponsor ID
- 20171192
- Conditions
- Lung Inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups: Healthy Volunteers and Volunteers with Documented ILD Diagnosis
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer Group | Experimental | Drug: Cu-DOTA-ECL1iThe healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group |
| ILD Documented Diagnosed Volunteer Group | Experimental | Drug: Cu-DOTA-ECL1iThe ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cu-DOTA-ECL1iRadiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy. | Drug | Healthy Volunteer Group, ILD Documented Diagnosed Volunteer Group |
Primary outcome
Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
Time frame: Through study completion
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
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
Time frame: Through study completion
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.
Determine rate of kinetics of Cu-DOTA-ECL1i
Time frame: Through study completion
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
1 secondary outcome
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
Time frame: Through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 32673071Brody 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.
- Individual participant dataSharing planned: Yes. DE-identified individual participant data for all primary and secondary outcome measures will be made available upon publication of trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Brody, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cu-DOTA-ECL1i in people with Lung Inflammation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Brody, MD (314-362-8969, brodys@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of uptake of Cu-DOTA-ECL1i to lung fibrosis (time frame: Through study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.