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PET Imaging CCR2 in Lung Inflammation

Primary Purpose

Lung Inflammation

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cu-DOTA-ECL1i

About this trial

This is an interventional diagnostic trial for Lung Inflammation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy Volunteer Group

ILD Documented Diagnosed Volunteer Group

Arm Description

The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group

The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group

Outcomes

Primary Outcome Measures

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

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.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03492762

First Posted

March 26, 2018

Last Updated

October 3, 2022

Sponsor

Washington University School of Medicine

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03492762

Brief Title

PET Imaging CCR2 in Lung Inflammation

Official Title

PET Imaging CCR2 in Lung Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Inflammation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

2 groups: Healthy Volunteers and Volunteers with Documented ILD Diagnosis

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteer Group

Arm Type

Experimental

Arm Description

The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group

Arm Title

ILD Documented Diagnosed Volunteer Group

Arm Type

Experimental

Arm Description

The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group

Intervention Type

Drug

Intervention Name(s)

Cu-DOTA-ECL1i

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of uptake of Cu-DOTA-ECL1i to lung fibrosis

Description

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

Title

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

Description

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

Title

Determine rate of kinetics of Cu-DOTA-ECL1i

Description

Time Frame

Through study completion

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Through study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven Brody, MD

Phone

314-362-8969

brodys@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Brody, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Brody, MD

Phone

314-362-8969

brodys@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

32673071

Citation

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.

Results Reference

derived

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