Evaluating a new imaging method for detecting atherosclerosis
PET Detection of CCR2 in Human Atherosclerosis
PHASE1 · Washington University School of Medicine · NCT04537403
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04537403 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe health conditions, such as type 1 diabetes or those in septic shock, may not benefit from this study.
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 performed: While this approach is novel, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carotid Atherosclerosis