Actively Recruiting
PET Detection of CCR2 in Human Atherosclerosis Using 64CU-DOTA-ECL1i Imaging
Led by Washington University School of Medicine · Updated on 2025-08-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of a new radioactive imaging medicine called 64CU-DOTA-ECL1i to evaluate arterial atherosclerosis, which is the buildup of plaque in arteries. This study includes both healthy volunteers and patients with carotid or femoral artery disease. The aim is to better visualize and understand plaque in these arteries, especially in patients scheduled for surgery or managed medically. The study is a Phase 1 interventional trial conducted by Washington University School of Medicine. Participants are divided into two groups. Group 1 includes healthy volunteers and patients who will undergo surgery; they receive a single imaging session lasting about 60 minutes with an injection of 64CU-DOTA-ECL1i to visualize their arteries. Plaque samples from surgery patients will be collected for further study. Group 2 consists of patients with artery disease who will not have surgery; they will have two imaging sessions spaced 7 to 14 days apart to assess the imaging performance of the radioactive tracer. During the study, participants will undergo imaging using PET and MR cameras to evaluate the characteristics and performance of the 64CU-DOTA-ECL1i tracer over 1 to 2 days. The research team will monitor imaging results and collect relevant data related to arterial atherosclerosis. Safety and tolerability, including the ability to remain still during imaging, will be assessed, and the total participation duration varies depending on group and imaging schedule.
CONDITIONS
Brief Title
PET Detection of CCR2 in Human Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal volunteers aged 18 to 40 years, non-smokers, with no history of diabetes, hypertension, or high cholesterol
- Patients aged 50 to 89 years with adequate nutritional status
- Patients with or without smoking history, diabetes, hypertension, and high cholesterol
- Both asymptomatic and symptomatic patients with carotid artery atherosclerosis greater than 70% plaque
- Patients scheduled for surgery or with advanced peripheral artery disease
You will not qualify if you...
- Unable to give informed consent
- Currently enrolled in another study
- Patients with type 1 diabetes or in septic shock
- Receiving steroid therapy
- Recent heavy alcohol consumption (men more than 2 drinks/day, women more than 1 drink/day)
- Following extreme diets like Atkins or South Beach
- Stage 4 chronic renal failure
- Unstable clinical condition as judged by the principal investigator
- Unable to tolerate 60 minutes lying on back with arms down
- Contraindications to MR imaging such as pacemaker, brain aneurysm clips, shrapnel
- Positive pregnancy test or lactating
- Having cancer or autoimmune/inflammatory diseases like rheumatoid arthritis or multiple sclerosis that increase CCR2 expression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo imaging sessions using 64CU-DOTA-ECL1i to evaluate arterial atherosclerosis.
1 imaging session for participants having surgery; 2 imaging sessions 7 to 14 days apart for participants not having surgery
Trial Site Locations
Total: 1 location
1
Washington University CCIR
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
K
Kitty Harrison, BSN, RN
R
Robert Gropler, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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