PET Imaging CCR2 in Lung Inflammation

NCT03492762 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 20171192R01HL151685-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Inflammation

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  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

  Through study completion

Study Arms (2)

Healthy Volunteer Group

EXPERIMENTAL

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

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

Drug: Cu-DOTA-ECL1i

Interventions

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.

Healthy Volunteer Group; ILD Documented Diagnosed Volunteer Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32673071 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven Brody, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Brody, MD

CONTACT

314-362-8969; brodys@wustl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups: Healthy Volunteers and Volunteers with Documented ILD Diagnosis

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 10, 2018
• Study Start: February 27, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 1 year of the study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)