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Cu-DOTA-ECL1i Imaging for Lung Inflammation

Phase < 1
Recruiting
Led By Steven Brody, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
No known history of cardiac, pulmonary, hepatic or renal disease or diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion
Awards & highlights

Study Summary

This trial is testing a new imaging probe to see if it is safe to use in order to scan for a certain protein.

Who is the study for?
This trial is for adults over 21 who either never smoked or are current smokers with a significant smoking history. They must be able to lie still for scans, have no illicit drug use in the past year, and normal lung function tests. Excluded are those with certain diseases, pregnant women, prescription medication users, and individuals with incompatible implanted devices.Check my eligibility
What is being tested?
The study is testing Cu-DOTA-ECL1i as a PET imaging radiotracer to see how well it can show the distribution of inflammatory cells in patients' lungs with fibrotic diseases. It includes multiple sub-studies focusing on scan reproducibility and correlation between scan results and actual cell distribution.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to lying still during scans such as discomfort or anxiety (for those with claustrophobia), plus any risks associated with exposure to radiotracers like allergic reactions or radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 21 or older and either never smoked or currently smoke at least half a pack a day.
Select...
I do not have a history of heart, lung, liver, kidney diseases or diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
Determine rate of kinetics of Cu-DOTA-ECL1i
Secondary outcome measures
Positron-Emission Tomography

Trial Design

2Treatment groups
Experimental Treatment
Group I: ILD Documented Diagnosed Volunteer GroupExperimental Treatment1 Intervention
The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group
Group II: Healthy Volunteer GroupExperimental Treatment1 Intervention
The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,592 Total Patients Enrolled
11 Trials studying Pneumonia
78,117 Patients Enrolled for Pneumonia
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,740 Total Patients Enrolled
4 Trials studying Pneumonia
2,722 Patients Enrolled for Pneumonia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,544 Total Patients Enrolled
14 Trials studying Pneumonia
23,436 Patients Enrolled for Pneumonia

Media Library

Healthy Volunteer Group Clinical Trial Eligibility Overview. Trial Name: NCT03492762 — Phase < 1
Pneumonia Research Study Groups: Healthy Volunteer Group, ILD Documented Diagnosed Volunteer Group
Pneumonia Clinical Trial 2023: Healthy Volunteer Group Highlights & Side Effects. Trial Name: NCT03492762 — Phase < 1
Healthy Volunteer Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03492762 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any limits to the number of participants in this research endeavor?

"Affirmative, the details available on clinicaltrials.gov suggest that this scientific endeavour is presently recruiting participants. It was first posted on February 27th 2018 and recently modified on October 3rd 2022; seeking 110 enrollees from a single medical site."

Answered by AI

Is there any availability in this research endeavor for interested participants?

"Data on clinicaltrials.gov affirms that this research endeavour is currently accepting applicants. This trial has been available since February 27th 2018, with the most recent update to its information being posted on October 3rd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PET Imaging CCR2 in Lung Inflammation
2018. "PET Imaging CCR2 in Lung Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03492762.
~14 spots leftby Mar 2025
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