Recruiting
Early Phase 1

PET Imaging

Sponsor:

Washington University School of Medicine

Code:

NCT03492762

Conditions

Lung Inflammation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Cu-DOTA-ECL1i

Study Details

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

Study ID

NCT03492762

Start date

Feb 27, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteer Group

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

experimental: ILD Documented Diagnosed Volunteer Group

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

Interventions

Cu-DOTA-ECL1i

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

  • Change of uptake of Cu-DOTA-ECL1i to lung fibrosis [ Time Frame: 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 rate of kinetics of Cu-DOTA-ECL1i [ Time Frame: Through study completion ]

Central Contacts and Locations

Central contacts

Steven Brody, MD

314-362-8969brodys@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Steven Brody, MD

314-362-8969brodys@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-05-01.