Clinical Trial Details
— Status: Approved for marketing
Administrative data
| NCT number |
NCT01764191 |
| Other study ID # |
BCCA-Cardiac PET |
| Secondary ID |
|
| Status |
Approved for marketing |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
February 2022 |
| Source |
British Columbia Cancer Agency |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial Summary
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
Description:
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 150 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.
