18F-FDG PET Imaging in Cardiac Sarcoidosis
|ClinicalTrials.gov Identifier: NCT01764191|
Expanded Access Status : Approved for marketing
First Posted : January 9, 2013
Last Update Posted : December 3, 2018
|First Submitted Date||January 3, 2013|
|First Posted Date||January 9, 2013|
|Last Update Posted Date||December 3, 2018|
|Brief Title||18F-FDG PET Imaging in Cardiac Sarcoidosis|
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
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.
|Study Type||Expanded Access|
|Intervention||Other: 18F-Fluorodeoxyglucose (18F-FDG) PET/CT
All subjects suspected of cardiac sarcoidosis will receive an intravenous dose of 18F-FDG (determined by weight, but not to exceed 521 MBq). Following an uptake phase of about 60 minutes, each subject will receive a PET/CT scan to evaluate the presence of cardiac sarcoidosis.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Canada|
|Removed Location Countries|
|Responsible Party||British Columbia Cancer Agency|
|Study Sponsor||British Columbia Cancer Agency|
|PRS Account||British Columbia Cancer Agency|
|Verification Date||November 2018|