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

Primary Purpose

Endocarditis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parametric positron emission computed tomography
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parametric positron emission computed tomography

Arm Description

Outcomes

Primary Outcome Measures

Determination of diagnostic value of parametric positron emission computed tomography
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 Outcome Measures

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

Full Information

First Posted
November 23, 2021
Last Updated
December 22, 2022
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT05146180
Brief Title
Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
Acronym
PARAVA
Official Title
Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parametric positron emission computed tomography
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Parametric positron emission computed tomography
Intervention Description
Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy
Primary Outcome Measure Information:
Title
Determination of diagnostic value of parametric positron emission computed tomography
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes
Description
comparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Chastan, MD
Phone
+33276673032
Email
mathieu.chastan@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Chastan, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Chastan, MD
Email
mathieu.chastan@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Doriane Richard, PhD
Email
doriane.richard@chb.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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