Evaluating a new imaging method for detecting atherosclerosis
Official title: PET Detection of CCR2 in Human Atherosclerosis
Run by Washington University School of Medicine · NCT04537403 · Data updated 2026-11-12
This study is testing a new imaging method using a special radioactive agent to see if it can better detect artery blockages in both healthy people and those with atherosclerosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | September 1, 2025 |
| Study ends | September 1, 2025 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT04537403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 50-89 with known carotid artery atherosclerosis greater than 70%, as well as normal volunteers aged 18-40 without significant health issues.
✕Probably not a fit
Patients with severe health conditions, such as type 1 diabetes or those in septic shock, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study uses a novel radioactive imaging agent, 64CUDOTA-ECL1i, to assess arterial atherosclerosis in both normal volunteers and patients with carotid or femoral artery atherosclerosis. Participants will be divided into two groups, both receiving the same imaging agent to evaluate its effectiveness in detecting the condition. The study aims to gather data on the safety and efficacy of this new imaging technique in identifying significant arterial blockages. It is designed as a Phase 1 interventional study to establish foundational knowledge for future research.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of carotid atherosclerosis, potentially reducing the risk of stroke.
How similar studies have gone: While this approach is novel, similar imaging techniques have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis \>70% and scheduled to undergo surgery. Advanced peripheral artery disease. \- Exclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male \>2 drinks per day, and female \> 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2. \-
Where it's running
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Washington University CCIR
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Kitty Harrison, BSN, RN
- Email: harrisonk@mir.wustl.edu
- Phone: 314-747-0183
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Photon-counting CT vs conventional CT for carotid plaque in people with carotid artery stenosis
This study tests whether photon-counting CT gives clearer, more detailed pictures of carotid plaques compared with standard CT in patients with carotid artery stenosis to help characterize plaque features.
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Carotid artery stenting during treatment of acute stroke
This study is testing if adding carotid artery stenting during a stroke treatment can help improve blood flow to the brain and lower the chances of having another stroke for patients with blocked carotid arteries.
-
Exploring the link between carotid atherosclerosis and coronary artery disease
This study looks at whether the buildup of plaque in the neck arteries is linked to heart artery disease in patients who have chest pain or tightness.
-
Assessing carotid plaque stiffness using ultrasound techniques
This study is testing a new ultrasound method to see if it can accurately measure how stiff plaque in the carotid arteries is, which might help doctors understand more about the condition and decide on treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.