Clinical trial · Interventional
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.
NCT04843891CI-TRIAL-00059261unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Sarcoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [64]Cu Macrin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Healthy Volunteers
- description
- In 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied.
- interventionNames
- Drug: [64]Cu Macrin
- type
- EXPERIMENTAL
- label
- Cardiovascular Disease
- description
- In 30 subjects with a history of recent myocardial infarct, the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied. In addition, the ability of \[64Cu\] Macrin to concentrate at the infarct site will be correlated with cardiac MRI.
- interventionNames
- Drug: [64]Cu Macrin
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDO'Shea A, Lewis AJM, Caravan P, Izquierdo-Garcia D, Le Fur M, Catalano OA, Montesi SB, Quintana JM, Carlson JCT, Dubach JM, Castro CM, Bobic M, Huesa-Berral C, Ng TSC, Bertolet A, Nahrendorf M, Weissleder R. First-in-Human Study of the Carbohydrate Nanoparticle 64Cu-Macrin. J Nucl Med. 2026 Mar 2;67(3):449-455. doi: 10.2967/jnumed.125.270770. PMID 41469153