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Radio-pharmaceutical

PET Imaging with 64CU-DOTA-ECL1i for Atherosclerosis

Phase 1
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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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Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 days
Awards & highlights

Study Summary

This trial tests a new imaging technique to diagnose hardening of the arteries, a major risk factor for stroke & heart attack.

Who is the study for?
This trial is for healthy volunteers aged 18-40 with no smoking history or chronic conditions, and patients aged 50-89 with carotid artery atherosclerosis over 70%, who may have various health issues like diabetes. Patients must be scheduled for surgery due to their condition.Check my eligibility
What is being tested?
The study tests a new radioactive imaging medicine called 64CU-DOTA-ECL1i on two groups of participants. The goal is to see how well this medicine can show the presence and severity of arterial atherosclerosis in these individuals.See study design
What are the potential side effects?
Since the intervention involves radioactive material, potential side effects might include reactions at the injection site, nausea, or allergic reactions. Long-term risks could involve exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of 64CU-ECL1i , imaging characteristics
Secondary outcome measures
PET/MR camera, imaging performance

Side effects data

From 2011 Phase 1 & 2 trial • 26 Patients • NCT00142415
100%
Fatigue
100%
Nausea
67%
Dyspepsia
67%
Abnormal faeces
33%
Constipation
33%
Bradycardia
33%
Tachycardia
33%
Diarrhoea
33%
Vomiting
33%
Nasopharyngitis
33%
Weight increased
33%
Back pain
33%
Headache
33%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250
Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250
Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250
Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250
Total
Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250
Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

Trial Design

2Treatment groups
Experimental Treatment
Group I: Aim 1BExperimental Treatment1 Intervention
Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery
Group II: Aim 1AExperimental Treatment1 Intervention
Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,773 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PET Detection of CCR2 in Human Atherosclerosis
2020. "PET Detection of CCR2 in Human Atherosclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04537403.
All > Atherosclerosis
~9 spots leftby Sep 2024
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