PET Detection of CCR2 in Human Atherosclerosis
Study Details
Study Description
Brief Summary
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aim 1A Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery |
Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)
Patients in Group 1, normal volunteers and patients with carotid and femoral artery disease who will be having surgery, will have a 1 day imaging session lasting approximately 60 minutes with an injection of 64CU-DOTA-ECL1i to visualize the carotid and femoral arteries. Patients with carotid and femoral artery disease will have their plaque specimens collected for further sutdy
|
| Experimental: Aim 1B Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery |
Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)
Patients in Group 2, who are patients with carotid and femoral artery disease who will not be having surgery will have two imaging sessions 7-14 days apart
|
Outcome Measures
Primary Outcome Measures
- Evaluation of 64CU-ECL1i , imaging characteristics [1 or 2 days]
Injecting normal volunteers and patients who have blocked arteries with a single bolus injection. The dose of the injection is 8-10, and the above drug is measured in millicuries, which is a unit of radioactivity. the dose of millicuries will be 8-10 millicures
Secondary Outcome Measures
- PET/MR camera, imaging performance [1-2 days]
Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage
Eligibility Criteria
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.
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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.
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University CCIR | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201911199