Carotid AtherosclerosisPhase 1NCT04537403
PET Detection of CCR2 in Human Atherosclerosis
A Phase 1 study testing Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine) and Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine) in people with Carotid Atherosclerosis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine) and Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University CCIR
St Louis, Missouri, 63110
Molly Mohrman
About this study
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis
Read the detailed description
Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..
- Conditions
- Carotid Atherosclerosis
- Being tested
- Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine), Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)Drug
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)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Aim 1A | Experimental | Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery Receives: Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine) |
| Aim 1B | Experimental | Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery Receives: Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 or 2 days
Secondary outcomes (1)
PET/MR camera, imaging performance
Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537403
- Sponsor's protocol ID
- 201911199
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Detection of CCR2 in Human Atherosclerosis
- ClinicalTrials.gov ID
- NCT04537403
- Acronym / sponsor ID
- 201911199
- Conditions
- Carotid Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1A | Experimental | Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery |
| Aim 1B | Experimental | Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Aim 1A |
| 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 | Drug | Aim 1B |
Primary outcome
Evaluation of 64CU-ECL1i , imaging characteristics
Time frame: 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
1 secondary outcome
PET/MR camera, imaging performance
Time frame: 1-2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Related trials for Carotid Atherosclerosis
Recruiting
Predicting High-Risk Carotid Plaque: Integrating radioMics and biomEchanics
Carotid Artery, Carotid Arteriosclerosis
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
RecruitingPhase 2
Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM), Atherosclerosis
Enrolling by invitationObservational study
The Role Oral Microbiome in the Development and Progression of Aorta Aneurysm and Carotid Atherosclerosis
Aorta Aneurysm, Carotid Arteriosclerosis
Not yet recruitingPhase 4
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Atherosclerosis Cerebral, Carotid Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine) and Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine) in people with Carotid Atherosclerosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kitty Harrison, BSN, RN (314-747-0183, harrisonk@mir.wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of 64CU-ECL1i , imaging characteristics (time frame: 1 or 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.