18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis (TEPvENDO)
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|ClinicalTrials.gov Identifier: NCT02287792|
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infective Endocarditis||Procedure: 18-FDG PET/CT scan||Not Applicable|
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.
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study|
|Actual Study Start Date :||April 17, 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||January 2017|
Experimental: 18-FDG PET/CT scan
All patients will undergo a whole body PET/CT scan
Procedure: 18-FDG PET/CT scan
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
- Proportion of patients with a change in IE therapeutic plan [ Time Frame: 7 days ]at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
- Proportion of patients with Duke-Li classification modifications [ Time Frame: 6 months ]Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
- Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures [ Time Frame: 6 months ]1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
- 6-month mortality rate [ Time Frame: 6 months ]number of dead patients 6 months after inclusion
- Determinants of change in therapeutic plan as defined in primary outcome [ Time Frame: 6 months ]Clinical and biological determinants of therapeutic changes
- 18-FDG PET/CT inter-reader reproducibility [ Time Frame: 6 months ]questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287792
|Bichat Claude Bernard Hospital|
|Paris, France, 75018|
|Principal Investigator:||Xavier Duval, Professor||Assistance Publique - Hôpitaux de Paris|