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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05146180
Acronym
PARAVA
Enrollment
30
Registered
2021-12-06
Start date
2022-02-24
Completion date
2027-03-01
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocarditis

Brief summary

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

Detailed description

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.

Interventions

DEVICEParametric positron emission computed tomography

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

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Determination of diagnostic value of parametric positron emission computed tomography3 monthsarea 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

MeasureTime frameDescription
Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes3 monthscomparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes

Countries

France

Contacts

Primary ContactMathieu Chastan, MD
mathieu.chastan@chb.unicancer.fr+33276673032
Backup ContactDoriane Richard, PhD
doriane.richard@chb.unicancer.fr+33232082985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026