RECRUITINGOBSERVATIONAL

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

Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DIAGNOSTIC_TEST

64Cu-DOTATATE PET/CT scan

Patients in group A-C will have a 64Cu-DOTATATE PET/CT scan performed in addition to routine clinical procedures. Group D has had 64Cu-DOTATATE PET/CT performed as part of their clinical diagnostic work-up or follow-up; these data are retrospectively identified and included in the study, and group D will not be subject to any scans in the study.

Locations (1)

Rigshospitalet

Copenhagen, Denmark