- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492762
PET Imaging CCR2 in Lung Inflammation
October 3, 2022 updated by: Washington University School of Medicine
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
110
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steven Brody, MD
- Phone Number: 314-362-8969
- Email: brodys@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Steven Brody, MD
- Phone Number: 314-362-8969
- Email: brodys@wustl.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy Volunteer Group
The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group
|
Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.
|
EXPERIMENTAL: ILD Documented Diagnosed Volunteer Group
The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group
|
Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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.
|
Through study completion
|
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
|
Through study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 27, 2018
Primary Completion (ANTICIPATED)
March 31, 2025
Study Completion (ANTICIPATED)
August 31, 2025
Study Registration Dates
First Submitted
March 26, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (ACTUAL)
April 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20171192
- R01HL151685-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
DE-identified individual participant data for all primary and secondary outcome measures will be made available upon publication of trial results.
IPD Sharing Time Frame
Data will be available within 1 year of the study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel.
Requestors will be required to sign a Data Access Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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