EndocarditisPARAVANCT05146180
Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
A study testing Parametric positron emission computed tomography in people with Endocarditis, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis
- What is being tested?
- Parametric positron emission computed tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Henri Becquerel
Rouen, 76000
Mathieu Chastan, MD, mathieu.chastan@chb.unicancer.fr
Doriane Richard, PhD, doriane.richard@chb.unicancer.fr
About this study
Official title: Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.
Read the 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.
- Conditions
- Endocarditis
- Being tested
- Parametric positron emission computed tomography
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parametric positron emission computed tomographyDevice
Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Parametric positron emission computed tomography | Experimental | Not described Receives: Device: Parametric positron emission computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start24 Feb 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Chastan, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146180
- Sponsor's protocol ID
- CHB18.10
- Acronym
- PARAVA
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2021
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
- ClinicalTrials.gov ID
- NCT05146180
- Acronym / sponsor ID
- PARAVA / CHB18.10
- Conditions
- Endocarditis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parametric positron emission computed tomography | Experimental | Device: Parametric positron emission computed tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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, ...),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parametric positron emission computed tomographyPatients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy | Device | Parametric positron emission computed tomography |
Primary outcome
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
1 secondary outcome
Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Endocarditis
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Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
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CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu Chastan, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parametric positron emission computed tomography in people with Endocarditis, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Chastan, MD (+33276673032, mathieu.chastan@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of diagnostic value of parametric positron emission computed tomography (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.