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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the diagnostic value of activated macrophage imaging in patients with or being evaluated for cardiac sarcoidosis using the PET/CT tracer 64Cu-DOTATATE. Cardiac sarcoidosis is a serious condition often causing death in affected patients, and current imaging methods like 18F-FDG PET/CT have limitations due to high uptake in normal heart muscle and require extensive patient preparation. The study seeks to find a tracer with better sensitivity and specificity that does not require such preparation or carry the same risks. Participants are divided into four groups: those with suspected cardiac sarcoidosis, those with confirmed cardiac sarcoidosis, those with suspected or confirmed acute lymphocytic myocarditis, and a control group of patients with neuroendocrine tumors who have previously undergone 64Cu-DOTATATE PET/CT scans. Groups A and B will receive both 64Cu-DOTATATE and 18F-FDG PET/CT scans, group C will have only the 64Cu-DOTATATE scan, and group D’s existing scan data will be included retrospectively. During the study, participants will undergo PET/CT scans to measure tracer uptake, which will help distinguish activated macrophages in the heart. Researchers will monitor and record tracer distribution and adverse outcomes over two years. The study includes clinical and imaging assessments to understand the patterns of inflammation in cardiac sarcoidosis and related conditions. Total participation time involves the scanning procedures and follow-up assessments over 24 months.
CONDITIONS
Brief 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 confirmed cardiac sarcoidosis (Group B)
- Patients with clinically suspected or confirmed acute lymphocytic myocarditis (Group C)
- Patients with neuroendocrine tumors without inflammatory heart disease previously scanned with 64Cu-DOTATATE PET/CT (Group D)
You will not qualify if you...
- Severe obesity (weight greater than 140 kg)
- Pregnancy (negative pregnancy test required for all fertile women)
- Severe claustrophobia
- Known allergy to 64Cu-DOTATATE
- Clinically critical condition preventing PET/CT scan
- Insulin-dependent diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint
Participants undergo 64Cu-DOTATATE PET/CT scans to evaluate macrophage presence in the heart for diagnosis of cardiac sarcoidosis or myocarditis. Additional routine clinical procedures may also be performed.
1 visit (in-person) for groups A, B, and C; group D includes previously performed scans with no additional visits
Duration - 2 years
Participants are observed for tracer uptake patterns and adverse outcomes over a 2-year period following imaging.
Visits as per routine clinical follow-up; no additional study visits required
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
F
Finn Gustafsson, MD,PhD,DMSc
A
Adelina Yafasova, MD
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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