Recruiting
Phase 1

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT04537403

Conditions

Carotid Atherosclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)

Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)

Study Details

Brief summary:

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

Conditions

Carotid Atherosclerosis

Study ID

NCT04537403

Start date

Oct 1, 2020

Status verified date

Jul, 2025

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Aim 1A

Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery

experimental: Aim 1B

Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery

Interventions

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

Primary outcome measure

  • Evaluation of 64CU-ECL1i , imaging characteristics [ Time Frame: 1 or 2 days ]

Central Contacts and Locations

Central contacts

Locations

Washington University CCIR

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-08-01.