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CompletedNCT01916005Updated Apr 24, 2023

Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

An interventional study of 18F-FDG PET/CT in Prosthetic Valve Endocarditis (PVE), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-24.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).

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Conditions studied

  • Prosthetic Valve Endocarditis (PVE)

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In context

Endocarditis

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

This study's enrollment of 174 is above the median of 77 across 82 interventional studies indexed under Endocarditis.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • unexplained persistent or recurrent fever >38°C;
  • and/or unexplained increased serum C-reactive protein (CRP) level >10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
  • and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
  • and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.

Exclusion criteria

Exclusion Criteria:

  • pregnancy,
  • an inability to lie flat,
  • a need for urgent cardiac surgery,
  • hemodynamic instability,
  • cardiac surgery \<1 month ago,
  • and a blood glucose level >1.8 g/L. Patients with a poor PET/CT image quality
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Study design

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

Study arms

  • Experimental
    endocarditis

    Device: 18F-FDG PET/CT

Interventions

  • Device18F-FDG PET/CT
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What researchers measure

Primary outcomes

  1. the diagnosis of prosthetic valve infective endocarditis

    18F-fluorodeoxyglucose positron emission tomography

    Time frame: 39months

Secondary outcomes

  1. the reproducibility of the technique,

    the other diagnostic parameters of PET/CT (specificity and predictive values)

    Time frame: 39 months

  2. the comparison of the sensitivity of PET/CT with that of echocardiography,

    the other diagnostic parameters of PET/CT (specificity and predictive values)

    Time frame: 39 MONTHS

  3. the rate of detection of embolic events,

    the other diagnostic parameters of PET/CT (specificity and predictive values)

    Time frame: 39 MONTHS

  4. the prognostic value of the technique (death/valve surgery)

    the other diagnostic parameters of PET/CT (specificity and predictive values)

    Time frame: 39 MONTHS

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Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01916005
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 5, 2013
Start date
Feb 5, 2014
Primary completion
Mar 20, 2018
Completion
Apr 21, 2023
Last update
Apr 24, 2023

Study contacts

LOIC MONDOLONI
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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