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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Infective Endocarditis Procedure: 18-FDG PET/CT scan Not Applicable

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  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Bichat Claude Bernard Hospital
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Duval, Professor Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02287792     History of Changes
Other Study ID Numbers: AOM13549
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Infective endocarditis
18-FDG PET/CT
Impact
Patient's management
Diagnostic

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action