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

July 24, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Bichat Claude Bernard Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects aged ≥ 18 years
  2. 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".
  3. Transthoracic or transesophageal ultrasound performed.
  4. A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
  5. Absence of cardiac surgery for the current IE episode
  6. Covered by the French health insurance system
  7. Having given and signed the written study informed consent to the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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…)
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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 months
6-month mortality rate
Time Frame: 6 months
number of dead patients 6 months after inclusion
6 months
Determinants of change in therapeutic plan as defined in primary outcome
Time Frame: 6 months
Clinical and biological determinants of therapeutic changes
6 months
18-FDG PET/CT inter-reader reproducibility
Time Frame: 6 months
questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Xavier Duval, Professor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM13549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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