PET Imaging with 64CU-DOTA-ECL1i for Atherosclerosis

Recruiting at 1 trial location

Overseen By Kitty Harrison, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Steroids

Disqualifiers: Type 1 diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radioactive drug, 64CUDOTA-ECL1i, to determine its effectiveness in detecting atherosclerosis (hardening of the arteries) using PET imaging. Researchers aim to see if this drug can identify artery issues in patients who might need surgery and those who won't. The trial involves two groups: one with individuals who have significant artery hardening and are scheduled for surgery, and another with individuals managed through medication. Those diagnosed with severe carotid artery atherosclerosis or advanced peripheral artery disease might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 64CUDOTA-ECL1i is safe for use in humans?

Research shows that 64Cu-DOTA-ECL1i is under investigation for its safety and effectiveness in detecting atherosclerosis, a condition where arteries become clogged. This process uses PET scans to locate specific cells in the heart that appear after a heart attack.

Early human studies suggest that this method can identify clogged areas in arteries without surgery. Although these are initial findings, they indicate the treatment might be well-tolerated. As a Phase 1 study, the primary goal is to determine safety, and the results will help identify any side effects.

Since the trial is in its early stages, detailed safety information might not yet be available. However, the focus on safety in this phase ensures that researchers closely monitor and report any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for atherosclerosis?

Researchers are excited about 64CU-DOTA-ECL1i because it offers a new way to visualize atherosclerosis using PET imaging. Unlike standard treatments that primarily manage symptoms and reduce risk factors, this approach targets the chemokine receptor CCR2, allowing for precise imaging of inflammation in arteries. This unique mechanism could help doctors better assess the severity of atherosclerosis and tailor treatments more effectively, potentially improving patient outcomes.

What evidence suggests that this treatment might be an effective treatment for atherosclerosis?

Research has shown that 64Cu-DOTA-ECL1i, a new imaging drug, could help identify atherosclerosis, a condition where arteries become clogged. In animal studies, it successfully highlighted areas of inflammation by targeting specific immune cells involved in the body's inflammatory response. This is significant because inflammation plays a key role in the development of atherosclerosis. Studies in mice have also demonstrated its ability to accurately visualize these inflamed areas. Although these findings are preliminary, they suggest that 64Cu-DOTA-ECL1i might be useful in detecting and understanding artery disease. In this trial, participants will be divided into two groups: one group will include normal volunteers and patients with carotid and femoral atherosclerosis undergoing surgery, while the other group will include patients with carotid and femoral atherosclerosis managed medically without surgery. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive a single bolus injection of 64CUDOTA-ECL1i and undergo PET/MR imaging to evaluate arterial atherosclerosis

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 64CUDOTA-ECL1i

Trial Overview 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.

How Is the Trial Designed?

Group I: Aim 1B Experimental Treatment 1 Intervention

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

Group II: Aim 1A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. withpower.com withpower.com/trial/phase-1-carotid-artery-diseases-9-2020-e119c

PET Imaging with 64CU-DOTA-ECL1i for Atherosclerosis This Phase 1 medical study run by Washington University School of Medicine is evaluating whether 64CUDOTA-ECL1i will have tolerable side effects & efficacy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7985841/

Current and Novel Radiopharmaceuticals for Imaging ... Cu-radiolabeled ECL1i (64Cu-DOTA-ECL1i) has been used for PET imaging of CCR2+ leukocytes in multiple animal models of inflammation, ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.124.324260

Visualizing Immune Checkpoint Inhibitors Derived ... Following anti-PD1 treatment for 8 weeks, 64Cu-DOTA-ECL1i PET/CT revealed significantly increased tracer uptake compared with groups treated ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0969805124000192

Development of a CCR2 targeted 18F-labeled radiotracer ... Our group has developed a peptide-based CCR2 targeted radiotracer (64Cu-DOTA-ECL1i) and showed promising results for atherosclerosis imaging in multiple mouse ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10261263/

[64Cu]Cu-DOTATATE PET metrics in the investigation of ... Both preclinical and clinical trials have demonstrated that PET imaging of vascular inflammation using radioactive-labeled DOTATATE is feasible.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11324396/

Uncovering atherosclerotic cardiovascular disease by PET ... 64Cu-DOTA-ECL1i is an example of a tracer that detects inflammatory CCR2+ monocytes and macrophages in the heart after MI (see the figure). These cells ...

7. atherosclerosis-journal.com atherosclerosis-journal.com/article/S0021-9150(25)00117-0/fulltext

a systematic review and meta-analysis of pre-clinical studies ... 64Cu-DOTA-ECL1i uptake, Lou et al. [16. 16. Lou, L. ∙ Detering, L ... These findings suggest that the increased risk of cardiovascular disease in patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9605050/

Emerging Nuclear Medicine Imaging of Atherosclerotic Plaque ... Another chemokine receptor, CCR2, may be visualized with a specific RP named 64Cu-DOTA-ECL1i, which was demonstrated by English et al.

9. grantome.com grantome.com/grant/NIH/R01-HL150891-02

PET Detection of CCR2 in Human Atherosclerosis Moreover, we have initial human subject PET data to suggest [64Cu]DOTA-ECL1i noninvasively detects atherosclerotic lesions. Our objective is to perform the ...