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NCT Number: NCT05146180

Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis

The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

Location status: Recruiting

Location contact

Doriane Richard, PhD

CONTACT

[email protected]

Mathieu Chastan, MD

CONTACT

[email protected]

About this study

In addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way.

The definitive diagnosis according to the Duke-Li criteria will be established three months later in a multidisciplinary consultation meeting.

The final diagnosis according to the Duke-Li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up.

Results and all the complementary work-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age superior to18 years,
  • Effective contraception for women of childbearing age or negative pregnancy test on the day of the exam
  • Good general condition. WHO ≤ 1
  • Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago
  • Labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography
  • Standard positron emission computed tomography planned as part of the extension assessment
  • Informed and signed consent before any specific study procedure.
  • Patient affiliated to the social security system

Exclusion criteria

  • Presence of an active cancer in the previous three years
  • Pregnancy or breastfeeding
  • Poorly controlled diabetic patients
  • Protected adults (under guardians or curators)
  • Impossible decubitus (orthopnea, ...),
  • Hypersensitivity to FDG or to one of the excipients of the radiopharmaceutical.

Treatment and study plan

Parametric positron emission computed tomography

Device

Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy

Primary outcomes

  1. Determination of diagnostic value of parametric positron emission computed tomography

    Time frame: 3 months

    area under the curve of the Ki parameter (and the Vd parameter) as a function of the presence of endocarditis diagnosed during the multidisciplinary consultation meeting at 3 months

Secondary outcomes

  1. Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes

    Time frame: 3 months

    comparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Mathieu Chastan, MD

CONTACT

[email protected]

+33276673032

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study

Acronym: PARAVA

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2021
Registry last updated
Jan 2, 2026

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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