PET Imaging CCR2 in Lung Inflammation

Who is this study for? Adult patients with Lung Inflammation
What treatments are being studied? Cu-64 DOTA-ECLi
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: t
View:

• 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

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Steven Brody, MD
brodys@wustl.edu
314-362-8969
Time Frame
Start Date: 2018-02-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 110
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov