Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-29 @ 12:21 AM
Study NCT ID:
NCT02287792
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEPvENDO
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: