Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 64Cu-DOTATATE PET/CT scan.
- Who it may be relevant to
- Registry conditions: Cardiac Sarcoidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis
Overview
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.
Interventions
- 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.
Primary outcome measures
- Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control) [Time frame: 2 years]
Secondary outcome measures (3)
- 24-month rates of adverse outcomes [Time frame: 2 years]
- Tracer uptake - myocarditis [Time frame: 2 years]
- Distribution of tracer uptake [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06131112 · H-23035676