PET Detection of CCR2 in Human Atherosclerosis

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

Study Overview

• Status: Recruiting
• Conditions: Carotid Atherosclerosis
• Intervention / Treatment: Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine); Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kitty Harrison, BSN, RN; Phone Number: 314-747-0183; Email: harrisonk@mir.wustl.edu
• Study Contact Backup: Name: Robert Gropler, M.D.; Phone Number: 314-747-0183; Email: groplerr@mir.wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University CCIR
      • Contact: Molly Mohrman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
• Other Study ID Numbers: 201911199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No