Trial Information

[18 F]-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET) in Cardiac Sarcoidosis

1. Purpose: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.

2. Hypothesis:18F-FDG PET/CT has greater sensitivity, specificity, and accuracy compared
to the current clinical gold standard of diagnosis for CS, the Japanese Ministry of
Health, Labour, and Welfare (MHLW) guidelines

3. Justification:Currently a clinical diagnosis CS is diagnosed using a combination of
diagnostic techniques including imaging and biopsy. Biopsies are challenging as it can
be difficult to locate the disease or access the desired biopsy location. MRI has been
proven effective but it is limited as patients with pacemakers and
cardioverter-defibrillators or patients with renal impairments are unable to have an
MRI. Finally radionuclide scintigraphy with Gallium-67 or Thallium-201 (201Tl) has been
useful, but can be non-specific for sarcoidosis. 18F-FDG PET/CT has significant
advantages over other radionuclide imaging modalities due to superior resolution of PET
coupled with the affinity of inflammatory cardiac tissue to metabolize FDG. 18F-FDG
PET/CT has been found to have higher sensitivity and specificity over other
conventionally used imaging modalities.

4. Research Method:This will be an expanded access study in which adult subjects with a
clinical suspicion of CS will be invited to participate, in order to identify potential
sites for biopsy or provide confirmation of the presence of CS. Based on population
extrapolation from all diagnosed or suspected cases of CS in British Columbia (BC), as
well as expert clinical opinion, it is estimated that 10 to 15 patients per year will
be enrolled in the study. Over a three year period, the expected sample size will be 30
- 45 patients. All subjects will receive an 18F-FDG PET/CT at the BC Cancer Agency
(BCCA) - Vancouver Centre.

5. Statistical Analysis:The planned sample size is 30-45 patients. The primary endpoint is
to provide PET/CT imaging to patients diagnosed with or suspected of CS. The secondary
end-point will be to assess the sensitivity, specificity and accuracy of 18F-FDG PET in
BC population. Confidence intervals of 95% will be used to assess this using exact
binomial distribution. All analyses will be performed in direct consultation with a
qualified statistician.

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.