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CompletedNCT03695861NATIVTEPUpdated Jun 1, 2026

Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

An interventional study of Whole-body 18F-FDG PET-CT scan in Endocarditis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).

Read the detailed description

Infectious endocarditis remains a serious pathology with an intra-hospital mortality of between 15 and 30%. The prognosis of patients depends on the speed of diagnosis and the beginning of the appropriate treatment.

Currently, the diagnosis of endocarditis is based on the ESC 2015 modified criteria. Echocardiography techniques play a key role, but can be negative in 20% of endocarditis. 18F-FDG PET-CT showed promising results in the management of prosthetic valve endocarditis and / or stimulation material.

However, few studies have been carried out on the contribution of PET-CT in the diagnosis of endocarditis on native valves, with discordant results. But this is the majority of endocarditis (70% of cases).

A 18F-FDG PET-CT will be performed in all patients included in the study in addition to standard care for endocarditis, within 5 days of the beginning of their management in the university hospital center of Bordeaux after verification of inclusion and exclusion criteria and signature of consent.

The included patients will be reviewed at Month 3 during a consultation with the completion of a clinical examination, an electrocardiogram, a biological assessment and a transthoracic ultrasound.

Adverse events and serious adverse events will be collected throughout the study.

02

Conditions studied

  • Endocarditis

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Keywords

  • Endocarditis Infectious
  • Native valve
  • ESC 2015 modified diagnostic criteria
  • 18F-FDG PET-CT
  • Detection of peripheral emboli
03

In context

Endocarditis

170 studies on the registry are indexed under Endocarditis; 51 are open to participants now.

This study's enrollment of 31 is below the median of 77 across 82 interventional studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate,
  • Affiliated person or beneficiary of a social security scheme,
  • Free, informed and written consent (no later than the day of inclusion and before any exam required by the research).

Exclusion criteria

Exclusion Criteria:

  • Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT,
  • Pregnant or nursing woman,
  • Patient who has already been treated for infective endocarditis within six months of enrollment,
  • Patient who had cardiac surgery in the two months preceding inclusion,
  • Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer,
  • Patient unable to sign consent,
  • Patient under legal protection,
  • Women of childbearing age who do not benefit from effective contraception (HAS criteria),
  • Patient in a period of relative exclusion from another research protocol.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Whole-body 18F-FDG PET-CT scan

    Diagnostic Test: Whole-body 18F-FDG PET-CT scan

Interventions

  • Diagnostic testWhole-body 18F-FDG PET-CT scan

    A 18F-FDG PET-CT will be performed within 5 days of the beginning of the patients care with infectious endocarditis at the University Hospital center of Bordeaux.

06

What researchers measure

Primary outcomes

  1. Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis

    The reference test in this study will be a "definite diagnosis" of infectious endocarditis according to the ESC 2015 modified criteria at three months of follow-up, evaluated by a multidisciplinary committee in infectious endocarditis. This evaluation will be done blind to the results of the PET-CT of the study. The index test 18F-FDG PET-CT will have been performed at the initial phase of patient management.

    Time frame: 3 month

07

Study locations

1 site
  • University hospital, Bordeaux
    Pessac, 33604, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03695861
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Oct 4, 2018
Start date
Nov 10, 2018
Primary completion
Sep 16, 2020
Completion
Sep 16, 2020
Last update
Jun 1, 2026

Study contacts

Cécile ALEXANDRINO, MD
principal investigator · University Hospital, Bordeaux
Paul PEREZ, MD,PhD
study chair · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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