Actively Recruiting
Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis: PARAVA Study
Led by Centre Henri Becquerel · Updated on 2026-01-02
30
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if early parametric positron emission computed tomography (PET) can help diagnose infections on heart valve prostheses. The study focuses on patients suspected of having endocarditis on a prosthetic heart valve implanted more than three months prior. It aims to assess the diagnostic value of this imaging method compared to standard tests and established diagnostic criteria. Participants will undergo a parametric PET scan about 15 days after having a labeled polynuclear scintigraphy. This advanced imaging is done alongside routine examinations like biological tests, ultrasounds, and leukocyte scintigraphy. The final diagnosis will be made three months later in a blinded multidisciplinary meeting using the Duke-Li criteria, incorporating standard PET and all other test results. During the study, patients will undergo scheduled imaging and standard tests. Researchers will evaluate the diagnostic accuracy of parametric PET at three months and its correlation with leukocyte scintigraphy. Participants must provide informed consent and be monitored for any adverse reactions. The study lasts at least three months from imaging to final diagnosis review, with ongoing data collection on imaging results and patient condition.
CONDITIONS
Brief Title
Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Women of childbearing age must use effective contraception or have a negative pregnancy test on the day of the exam
- Good general health with WHO performance status of 1 or less
- Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago
- Labeled polynuclear scintigraphy performed within 15 days before positron emission computed tomography
- Standard positron emission computed tomography planned as part of the assessment
- Informed and signed consent obtained before any study procedure
- Affiliated with the social security system
You will not qualify if you...
- Active cancer within the past three years
- Pregnant or breastfeeding women
- Poorly controlled diabetes
- Individuals under guardianship or curatorship
- Unable to lie down flat due to conditions like orthopnea
- Hypersensitivity to FDG or any excipients of the radiopharmaceutical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 days
Participants undergo parametric positron emission computed tomography approximately 15 days after labeled polynuclear scintigraphy as part of the diagnostic process.
1 visit (in-person)
Duration - 3 months
Participants are observed and diagnosed definitively according to the Duke-Li criteria during a multidisciplinary consultation meeting 3 months after diagnostic evaluations.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Centre Henri Becquerel
Rouen, France, 76000
Actively Recruiting
Research Team
M
Mathieu Chastan, MD
D
Doriane Richard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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