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

  • STATUS
    Recruiting
  • days left to enroll
    59
  • participants needed
    100
  • sponsor
    Ralph Weissleder, MD
Updated on 7 July 2022
cancer
myocardial infarction
infarct
percutaneous coronary intervention
primary cancer
Accepts healthy volunteers

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.

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.

Details
Condition Sarcoid, Cardiovascular Diseases, Cancer
Treatment [64]Cu Macrin
Clinical Study IdentifierNCT04843891
SponsorRalph Weissleder, MD
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Group 1: Healthy subjects
Must be 18 years of age or older
Must be deemed healthy at screening visit, as determined by the physician investigator or nurse practitioner, based on the following assessments at screening: physical examination, medical history and vital signs
No known history of pre-existing cardiac or respiratory disease or malignancy
Have the ability to give written informed consent
Group 2: Myocardial Infarction
History of percutaneous coronary intervention (PCI) for acute or chronic coronary syndrome (within 3-5 days)
Have the ability to give written informed consent
Must be 18 years of age or older
Hemodynamically stable
Group 3: Sarcoidosis
A suspected or confirmed diagnosis of intrathoracic sarcoidosis
Have the ability to give written informed consent
Must be 18 years of age or older
Group 4: Malignancy
Suspected or confirmed thoracic, intra-abdominal or pelvic malignancy
Have the ability to give written informed consent
Must be 18 years of age or older

Exclusion Criteria

• Electrical implants, such as cardiac pacemaker or perfusion pump
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
eGFR of less than 30 mL/min/1.73 m2 within the past 30 days
Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
Self-reported or documented claustrophobic reactions
Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months)
Unable to lie comfortably on a bed inside the MR-PET
BMI > 33 (limit of the PET-MRI table)
Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures)
Stroke within the last 3 months
Cardiac or major surgery within the last 3 months
History of abnormal heart rate including persistent tachyarrhythmia (heart rate persistently >120 bpm) or bradyarrhythmia (heart rate persistently < 50 bpm)
History of atrial premature complexes with daytime pauses > 3s
Contraindications to gadolinium-based contrast agents, including an eGFR < 30 mL/min (myocardial infarction and sarcoidosis patients only)
History of myeloproliferative disorder
Age >80 years
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