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

NCT ID: NCT05146180

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Endocarditis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Parametric positron emission computed tomography

Group Type EXPERIMENTAL

Parametric positron emission computed tomography

Intervention Type DEVICE

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

Interventions

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Parametric positron emission computed tomography

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu Chastan, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathieu Chastan, MD

Role: CONTACT

Phone: +33276673032

Email: [email protected]

Doriane Richard, PhD

Role: CONTACT

Phone: +33232082985

Email: [email protected]

Facility Contacts

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Mathieu Chastan, MD

Role: primary

Doriane Richard, PhD

Role: backup

Other Identifiers

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CHB18.10

Identifier Type: -

Identifier Source: org_study_id