PET Imaging CCR2 in Lung Inflammation

The Washington University

Status and phase: Enrolling; Early Phase 1

Conditions: Lung Inflammation

Treatments: Drug: Cu-DOTA-ECL1i

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03492762

20171192

R01HL151685-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Healthy Volunteer Group

Experimental group

Description:

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

Treatment:

Drug: Cu-DOTA-ECL1i

ILD Documented Diagnosed Volunteer Group

Experimental group

Description:

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

Treatment:

Drug: Cu-DOTA-ECL1i