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Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis

Recruitingn/aAges 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06131112 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls. Participants will be included in the following groups: Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age =\> 18 years * Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group) Exclusion Criteria: * Severe obesity (weight \> 140 kg) * Pregnancy (negative point-of-care urine/serum human chorion gonadotropin is required in all fertile women) * Severe claustrophobia * Known allergy to 64Cu-DOTATATE * Clinically critical condition which makes PET/CT impossible * Diabetes with insulin dependence
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What it tests

  • 64Cu-DOTATATE PET/CT scan
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Where

1 site
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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