PET Detection of CCR2 in Human Atherosclerosis

Carotid Atherosclerosis Clinical Trial

Official title:

PET Detection of CCR2 in Human Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537403
• Other study ID #: 201911199
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Kitty Harrison, BSN, RN
• Phone: 314-747-0183
• Email: harrisonk[@]mir.wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis

Description:

Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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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Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Washington University CCIR	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of 64CU-ECL1i , imaging characteristics	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	1 or 2 days
Secondary	PET/MR camera, imaging performance	Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage	1-2 days