64Cu-DOTA-ECL1i for Heart Attack

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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the feasibility of 64Cu-DOTA-ECL1i, an investigational PET imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.

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.

What data supports the effectiveness of the treatment 64Cu-DOTA-ECL1i for heart attack?

Research shows that 64Cu-DOTA-ECL1i can effectively detect specific immune cells involved in heart injury in animal models, suggesting it could help in diagnosing heart conditions. Additionally, similar copper-based compounds have been used safely and effectively in imaging for cancer, indicating potential for broader diagnostic applications. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Targeted PET Imaging of Chemokine Receptor 2-Positive Monocytes and Macrophages in the Injured Heart. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Preclinical PET imaging study of lung cancer with 64CuCl2. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Copper in Cancer Imaging and Therapy: A New Theragnostic Agent. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Synthesis of DOTA-pyridine chelates for 64Cu coordination and radiolabeling of αMSH peptide. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

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