Status:
RECRUITING
Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Cardiac Sarcoidosis
Eligibility:
All Genders
18+ years
Brief Summary
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 use...
Detailed Description
Cardiac involvement is considered a serious condition and a frequent cause of death in patients with sarcoidosis. 18F-FDG PET/CT is currently used as part of the diagnostic criteria for cardiac sarcoi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06131112
Start Date
November 1 2023
End Date
January 1 2027
Last Update
November 18 2023
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark