Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
- Conditions
- Cardiac Sarcoidosis
- Interventions
- Diagnostic Test: 64Cu-DOTATATE PET/CT scan
- Registration Number
- NCT06131112
- Lead Sponsor
- Rigshospitalet, Denmark
- 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 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)
- 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 sarcoidosis, but it has shown limitations in the evaluation of cardiac sarcoidosis due to the high physiological uptake of FDG in normal cardiac muscle. Elaborate preparations are required for patients including either a low-carbohydrate diet followed by long fasting or heparin loading before FDG-PET. In heparin loading, the rare adverse effect of heparin-induced thrombocytopenia should be considered. Therefore, it is of interest to find a PET/CT tracer that displays high sensitivity and specificity without requiring thorough patient preparation and minimizing any adverse effects.
A potential tracer is the somatostatin-based tracer 64Cu-DOTATATE, which is routinely used for the diagnosis and monitoring of treatment response in patients with neuroendocrine tumors. Inflammatory cells, including macrophages that are found in sarcoid granulomas, express somatostatin receptors on their surface, whereas normal cardiomyocytes do not. This allows for the potential use of macrophage imaging in cardiac sarcoidosis.
In the CuDOSIS trial, groups A and B (suspected and confirmed cardiac sarcoidosis, respectively) will be scanned with 64Cu-DOTATATE PET/CT in addition to the routinely performed 18F-FDG PET/CT. Further, to examine whether the macrophage infiltration pattern is different in patients with cardiac sarcoidosis and other inflammatory heart diseases, a group of patients with confirmed or clinically suspected myocarditis will be included (group C); this group will only be scanned with 64Cu-DOTATATE PET/CT. Finally, data from a group of patients with neuroendocrine tumours (negative controls) who have previously been scanned with 64Cu-DOTATATE will be included.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A 64Cu-DOTATATE PET/CT scan 22 patients with clinically suspected cardiac sarcoidosis Group B 64Cu-DOTATATE PET/CT scan 22 patients with known cardiac sarcoidosis Group C 64Cu-DOTATATE PET/CT scan Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis
- Primary Outcome Measures
Name Time Method Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control) 2 years The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified cardiac sarcoidosis and the proportion of patients without tracer uptake in the heart on 64Cu-DOTATATE PET/CT for patients with a neuroendocrine tumor without a history of inflammatory heart disease (the control group).
- Secondary Outcome Measures
Name Time Method Distribution of tracer uptake 2 years The distribution of tracer uptake in the heart in patients with cardiac sarcoidosis and acute lymphocytic myocarditis, respectively
Tracer uptake - myocarditis 2 years The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified acute lymphocytic myocarditis
24-month rates of adverse outcomes 2 years Death, heart failure hospitalizations, decrease of left ventricular ejection fraction to \<10% and \<50%, new-onset ventricular tachycardia, new-onset atrioventricular block, implantable cardioverter-defibrillator implantation, shocks from implantable cardioverter-defibrillator, pacemaker implantation, cardiac resyncronization therapy
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark