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This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care.
The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population
Full description
Sensitivity (ratio of true positive lesions to total positive lesions), specificity (ratio of true negative lesions to total negative lesions) and accuracy (ratio of total correct studies to the total number of biopsied lesions) of 18F-FDG PET studies performed by the BCCA will be obtained by comparing results of the PET scan with a composite of the outcome of clinical examinations, histopathological diagnosis, if those results are available, and results of all other available imaging (cardiac MRI, 201Tl, 67Ga). Confidence intervals (95% CI) for sensitivity, specificity and accuracy will be calculated using exact binomial distribution.
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Inclusion criteria
Age 19 years or older.
Eastern Cooperative Oncology Group(ECOG) performance status 0 - 3.
Able to provide written informed consent.
Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 45 minutes and tolerating intravenous cannulation for injection.
Clinical suspicion of cardiac sarcoidosis, including a combination of:
Routine tests for CS are inconclusive, such as:
Patient has renal dysfunction which limits other radionuclide imaging.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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