Actively Recruiting
Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
Led by Rigshospitalet, Denmark · Updated on 2023-11-18
76
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with clinically suspected cardiac sarcoidosis (Group A)
- Patients with known cardiac sarcoidosis (Group B)
- Patients with suspected or confirmed acute lymphocytic myocarditis (Group C)
- Patients with neuroendocrine tumors previously scanned with 64Cu-DOTATATE as part of routine care (Group D, control group)
You will not qualify if you...
- Severe obesity (weight over 140 kg)
- Pregnancy (negative pregnancy test required for women of childbearing potential)
- Severe claustrophobia
- Known allergy to 64Cu-DOTATATE
- Clinically critical condition preventing PET/CT
- Insulin-dependent diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
F
Finn Gustafsson, MD,PhD,DMSc
CONTACT
A
Adelina Yafasova, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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