PET Detection of CCR2 in Human Atherosclerosis

The Washington University

Status and phase: Enrolling; Phase 1

Conditions: Carotid Atherosclerosis

Treatments: Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine); Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)

Study type: Interventional

Funder types: Other

Identifiers

NCT04537403

201911199

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Aim 1A

Experimental group

Description:

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

Treatment:

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

Aim 1B

Experimental group

Description:

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

Treatment:

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