PET Detection of CCR2 in Human Atherosclerosis

Phase 1

Recruiting

• Conditions: Carotid Atherosclerosis
• Interventions: Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine); Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)

• Registration Number: NCT04537403
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-03
• Study Start: 2020-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aim 1A	Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)	Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery
Aim 1B	Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)	Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University CCIR; 🇺🇸 Saint Louis, Missouri, United States