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

Recruiting now

Conditions studied: Cardiac Sarcoidosis

In brief

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 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)

Key facts

Study ID

NCT06131112

Run by

Rigshospitalet, Denmark

People needed

76

Starts

2023-11-01

Expected to finish

2027-01-01

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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