64Cu-DOTA-ECL1i for Heart Attack

Not currently recruiting at 1 trial location

Overseen By Kitty D Harrison, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Prescription medications

Disqualifiers: Diabetes, Hypertension, Heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new PET imaging drug called 64Cu-DOTA-ECL1i (Copper Cu 64-DOTA-ECL1i) to evaluate its effectiveness in detecting heart damage at the cellular level. It targets individuals who have experienced a heart attack or have other heart issues, such as inflammation or device infections. The study will compare results across various heart conditions. Ideal candidates include those who have had a heart attack within the last 6 months or have specific inflammatory heart diseases and can remain still for imaging tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are a healthy volunteer, you cannot be taking any prescription medications to participate.

Is there any evidence suggesting that 64Cu-DOTA-ECL1i is likely to be safe for humans?

Research has shown that 64Cu-DOTA-ECL1i is similar to another imaging drug, Copper Cu 64 dotatate, used in PET scans. In past studies with Copper Cu 64 dotatate, common side effects included nausea, vomiting, and flushing. More serious side effects, such as chest tightness and trouble swallowing, were also reported. These side effects might indicate what to expect with 64Cu-DOTA-ECL1i, although few studies have been conducted on this specific drug.

As this trial is in its early stages, the researchers aim to determine the drug's safety and the appropriate dose. Consequently, there is limited information on how well people can tolerate 64Cu-DOTA-ECL1i. Participants in the trial will contribute to gathering this crucial safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 64Cu-DOTA-ECL1i because it offers a novel approach to imaging heart conditions like heart attacks, cardiomyopathy, and myocarditis. Unlike traditional imaging methods, which may rely on broader or less specific markers, 64Cu-DOTA-ECL1i utilizes a unique radiolabeled compound that targets specific cells involved in inflammation and tissue damage. This precision allows for more accurate assessments of heart damage and inflammation, potentially leading to better-targeted treatments. Additionally, the use of copper-64 as a radiotracer can provide clearer images with less radiation exposure compared to some existing methods. Overall, this innovative imaging agent could revolutionize how heart conditions are diagnosed and monitored.

What evidence suggests that 64Cu-DOTA-ECL1i is effective for heart attack imaging?

Research has shown that 64Cu-DOTA-ECL1i holds promise for detecting inflammation in the heart after a heart attack. This trial includes different arms to image patients with various conditions. In the arm focusing on post-ST elevation myocardial infarction (heart attack), this tracer targets specific cells called CCR2+ monocytes and macrophages, which often contribute to heart inflammation following heart issues like a heart attack. One study found that individuals who recently experienced heart attacks showed greater uptake of this tracer in their hearts compared to healthy individuals, suggesting it can identify inflamed areas. Other arms in this trial will image conditions such as myocarditis and sarcoidosis, as early findings suggest the tracer might be effective for these heart diseases involving inflammation. Overall, this imaging drug aims to detect inflammation at the cellular level, potentially aiding in the treatment of heart conditions. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 who've had a severe heart attack or inflammatory heart disease within the last 6 months. Participants must be stable enough for PET scans, not use illicit drugs, and can't be pregnant. Those over 300 lbs or with conditions like uncontrolled heart failure or hypertension are excluded.

Inclusion Criteria

I can lie still for an hour and follow breathing instructions during a scan.

Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol

I am between 21 and 80 years old and willing to volunteer for a study.

Exclusion Criteria

My heart condition is not well-managed.

You are currently using illegal drugs for fun.

I experience chest pain due to heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo PET/MR and PET/CT imaging to evaluate the feasibility of 64Cu-DOTA-ECL1i in detecting CCR2+ monocytes and macrophages in the myocardium

1 or 2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 64Cu-DOTA-ECL1i

Trial Overview

The study tests an experimental PET imaging drug called 64Cu-DOTA-ECL1i to see if it can safely show inflammation in the heart after a serious heart attack or due to other inflammatory heart diseases.

How Is the Trial Designed?

Group I: Cardiomyopathy Active Control 1 Intervention

Image patients with cardiomyopathy

Group II: Infected Cardiovascular Implantable Electronic Devices Active Control 1 Intervention

Image patients with cardiovascular implanted medical devices

Group III: Post ST Elevation Myocardial Infarction/ Heart Attack Active Control 1 Intervention

Image patients who have had a heart attack

Group IV: Myocarditis Active Control 1 Intervention

Image patients with Myocarditis

Group V: Sarcoidosis Active Control 1 Intervention

Image patients who have Sarcoidosis

Group VI: Healthy Volunteers Active Control 1 Intervention

Image healthy volunteers

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Copper-64 (64Cu) is a promising PET/CT tracer for diagnosing various cancers, including prostate cancer and glioblastoma, due to its ability to target copper-avid tumors and its favorable nuclear properties for both imaging and therapy.

Studies indicate that 64CuCl2 is safe in terms of radiation and toxicology, making it a viable option for theragnostic applications in oncology, particularly for imaging and potentially treating cancers like hepatocellular carcinoma and malignant melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Copper in Cancer Imaging and Therapy: A New Theragnostic Agent. Capriotti, G., Piccardo, A., Giovannelli, E., et al.[2023]

The study developed a series of chelators (DOTA-xPy) that significantly improve the labeling yield of the radioisotope 64Cu, achieving quantitative complexing within 5 minutes at room temperature.

The chelators demonstrated excellent stability in human serum for up to 24 hours and maintained high binding affinity to the melanocortin 1 receptor, indicating their potential for use in theranostic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of DOTA-pyridine chelates for 64Cu coordination and radiolabeling of αMSH peptide. Yang, H., Gao, F., McNeil, B., et al.[2021]

The study successfully used 64Cu-DOTA-ECL1i PET imaging to detect proinflammatory CCR2+ monocytes and macrophages in various heart injury models, demonstrating its effectiveness and specificity.

Flow cytometry confirmed that CCR2 is specifically expressed on these immune cells, and the tracer also binds to human CCR2, paving the way for potential clinical applications in imaging heart diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted PET Imaging of Chemokine Receptor 2-Positive Monocytes and Macrophages in the Injured Heart. Heo, GS., Bajpai, G., Li, W., et al.[2022]

The study demonstrated that the copper transporter 1 (CTR1) is overexpressed in various lung cancer cell lines, and the uptake of the tracer copper (II)-64 chloride (64CuCl2) is directly related to the levels of CTR1 expression, indicating its potential for targeted imaging.

Small animal PET imaging confirmed that 64CuCl2 can effectively visualize CTR1 expression in lung cancer tumors, suggesting it could be a valuable tool for PET imaging in clinical lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical PET imaging study of lung cancer with 64CuCl2. Wang, Q., Song, D., Ma, X., et al.[2022]

Copper-64 chloride (64CuCl2) is a promising radiotracer for cancer imaging using PET, showing safety in humans and effective imaging for various cancers including prostate, bladder, and glioblastoma.

The dual emission of β+ and β- particles from 64CuCl2 suggests its potential not only for imaging but also for therapeutic applications in treating copper-avid tumors, especially with the development of the therapeutic copper-67 radionuclide for combined imaging and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Cancer Imaging with 64CuCl2 PET/CT. Peng, F.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6435034/

Molecular Imaging Visualizes Recruitment of Inflammatory ...

The 64Cu-DOTA-ECL1i tracer specifically detects CCR2+ monocyte and macrophage accumulation within the lung following ischemia reperfusion injury and ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071358124006883

Novel tracers to assess myocardial inflammation with ...

Notably, a feasibility study is currently evaluating 64Cu-DOTA-ECL1i PET imaging in patients with various inflammatory heart diseases, including post-AMI, CS, ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38947883/

CCR2 Imaging in Human ST-Segment Elevation Myocardial ...

Compared to healthy controls, 64Cu-DOTA-ECL1i heart uptake was increased in subjects following acute myocardial infarction, predominately localized within the ...

4.

journalofnuclearcardiology.org

journalofnuclearcardiology.org/article/S1071-3581(24)00688-3/fulltext

Novel tracers to assess myocardial inflammation with ...

Notably, a feasibility study is currently evaluating 64Cu-DOTA-ECL1i PET imaging in patients with various inflammatory heart diseases, including ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2452302X25000671

Chemokine Receptor 2 Is a Theranostic Biomarker for ...

In this study, [64Cu]Cu-DOTA-ECL1i demonstrated its sensitivity and specificity of imaging CCR2 expression in AAA progression and monitoring CCR2 inhibitor ...

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/copper-cu-64-dotatate-intravenous-route/description/drg-20502439

Copper cu 64 dotatate (intravenous route) - Side effects & ...

Copper Cu 64 dotatate injection is used with a PET scan (positron emission tomography) for localization of somatostatin receptor positive neuroendocrine tumors ...

7.

rxlist.com

rxlist.com/copper_cu_64_dotatate/generic-drug.htm

Copper CU 64 Dotatate: Side Effects, Uses, Dosage ...

Nausea,; Vomiting, and; Flushing. Serious side effects of Copper CU 64 Dotatate include: Chest tightness; Cough; Difficulty with swallowing ...

8.

drugs.com

drugs.com/cons/copper-cu-64-dotatate.html

Copper cu 64 dotatate Advanced Patient Information

Side Effects of copper cu 64 dotatate · Chest tightness · cough · difficulty with swallowing · dizziness · fast heartbeat · hives, itching, or skin ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9895323/

Scale down and optimized automated production of [68Ga ...

Radionuclides used for the radiolabeling are gallium-68 and cupper-64, and 64Cu-DOTA-ECL1i is reported in the NCI Drug Dictionary as a PET tool ...

10.

cancer.gov

cancer.gov/publications/dictionaries/cancer-drug/def/copper-cu-64-dota-ecl1i

Definition of copper Cu 64-DOTA-ECL1i

Upon administration, the ECL1i moiety targets and allosterically binds to CCR2 expressing tumor cells. Upon PET imaging, the copper Cu 64 moiety can be ...