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Completed

NCT Number: NCT02287792

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bichat Claude Bernard Hospital

Paris, 75018, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged ≥ 18 years
  • Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
  • Transthoracic or transesophageal ultrasound performed.
  • A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
  • Absence of cardiac surgery for the current IE episode
  • Covered by the French health insurance system
  • Having given and signed the written study informed consent to the study.

Exclusion criteria

  • Patient having already had a 18-FDG PET/CT in the current episode
  • Contraindication to perform a 18-FDG PET/CT
  • Early prosthetic valve IE (cardiac surgery within last 2 months)
  • Inability to understand the information form
  • Pregnant or lactating woman.
  • Cardiac surgery between inclusion and 18-FDG PET/CT
  • Participation to any clinical trial including 18-FDG PET/CT

Treatment and study plan

18-FDG PET/CT scan

Procedure

Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis

Primary outcomes

  1. 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…)

Secondary outcomes

  1. 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

  2. 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

  3. 6-month mortality rate

    Time frame: 6 months

    number of dead patients 6 months after inclusion

  4. Determinants of change in therapeutic plan as defined in primary outcome

    Time frame: 6 months

    Clinical and biological determinants of therapeutic changes

  5. 18-FDG PET/CT inter-reader reproducibility

    Time frame: 6 months

    questionnaire

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study

Acronym: TEPvENDO

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 11, 2014
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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