Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT02287792
Brief Summary:
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Detailed Description:
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
Primary objective:
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
Secondary objectives:
* To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis
* To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE
* To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry
* To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate
* To identify clinical and biological determinants of extracardiac IE localizations and prognosis
* To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method
Study:
NCT02287792
Study Brief:
Protocol Section:
NCT02287792