NCT04843891

Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.

Preliminary Evaluation of [64Cu] Macrin in Healthy Individuals and Subjects With Cardiovascular Disease, Sarcoidosis and Malignancy.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ralph Weissleder, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety of \[64Cu\] Macrin and its whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. To detect \[64Cu\]-Macrin accumulation in sites of disease in subjects with cancer, sarcoidosis or myocardial infarct.

Detailed description

Macrophages are phagocytic cells of the innate immune system. Their accumulation is a hallmark of many inflammatory diseases and they have diverse roles in tissue responses to infection and injury and in tissue repair. As macrophages have a tissue specific and often disease stage specific roles, future therapies directed at macrophage subtypes at certain points in the course of a disease may be more efficacious and result in less systemic side effects, as compared to conventional chemotherapeutics. \[64Cu\] Macrin is designed to detect macrophages by PET imaging. As a result, PET imaging can be used to identify inflammatory "hotspots" and quantitate local macrophage density non-invasively. The investigators studies in mice showed that \[64Cu\] Macrin has excellent pharmacological and pharmacokinetic profile with high target uptake and low retention in background tissues and organs. The investigators wish to first evaluate in healthy human subjects the pharmacological and pharmacokinetic profile, and the overall safety of the new radiopharmaceutical \[64Cu\] Macrin. The investigators will then establish the concentration of \[64Cu\] Macrin in patients following myocardial infarct, in sarcoidosis and in cancer patients. In a subset of patients where tissue sampling is feasible, we will correlate tracer uptake on imaging to macrophage density on histopathology or with additional standard of care imaging studies.

Conditions

• Sarcoid
• Cardiovascular Diseases
• Cancer

Interventions

Type	Name	Description
DRUG	[64]Cu Macrin	Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.

Timeline

• Start date: 2021-09-06
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2021-04-14
• Last updated: 2022-06-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study