18-FDG PET/CT Imaging & Clinical Decisions in Infective Endocarditis

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02287792
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	April 17, 2015
Completion date	January 2017

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis — TEPvENDO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms