18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis
TEPvENDO
Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedStudy Start
First participant enrolled
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedAugust 8, 2025
July 1, 2017
12 months
October 31, 2014
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a change in IE therapeutic plan
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
7 days
Secondary Outcomes (5)
Proportion of patients with Duke-Li classification modifications
6 months
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
6 months
6-month mortality rate
6 months
Determinants of change in therapeutic plan as defined in primary outcome
6 months
18-FDG PET/CT inter-reader reproducibility
6 months
Study Arms (1)
18-FDG PET/CT scan
EXPERIMENTALAll patients will undergo a whole body PET/CT scan
Interventions
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
Eligibility Criteria
You may qualify if:
- Subjects aged ≥ 18 years
- Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
- Transthoracic or transesophageal ultrasound performed.
- A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
- Absence of cardiac surgery for the current IE episode
- Covered by the French health insurance system
- Having given and signed the written study informed consent to the study.
You may not qualify if:
- Patient having already had a 18-FDG PET/CT in the current episode
- Contraindication to perform a 18-FDG PET/CT
- Early prosthetic valve IE (cardiac surgery within last 2 months)
- Inability to understand the information form
- Pregnant or lactating woman.
- Participation to any clinical trial including 18-FDG PET/CT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bichat Claude Bernard Hospital
Paris, 75018, France
Related Publications (3)
Boursier C, Duval X, Bourdon A, Imbert L, Mahida B, Chevalier E, Claudin M, Hoen B, Goehringer F, Selton-Suty C, Roch V, Lamiral Z, Humbert O, Rouzet F, Marie PY; AEPEI-TEPvENDO study group. ECG-Gated Cardiac FDG PET Acquisitions Significantly Improve Detectability of Infective Endocarditis. JACC Cardiovasc Imaging. 2020 Dec;13(12):2691-2693. doi: 10.1016/j.jcmg.2020.06.036. Epub 2020 Aug 19. No abstract available.
PMID: 32828775BACKGROUNDDuval X, Le Moing V, Tubiana S, Esposito-Farese M, Ilic-Habensus E, Leclercq F, Bourdon A, Goehringer F, Selton-Suty C, Chevalier E, Boutoille D, Piriou N, Le Tourneau T, Chirouze C, Seronde MF, Morel O, Piroth L, Eicher JC, Humbert O, Revest M, Thebault E, Devillers A, Delahaye F, Boibieux A, Gregoire B, Hoen B, Laouenan C, Iung B, Rouzet F; AEPEI-TEPvENDO study group. Impact of Systematic Whole-body 18F-Fluorodeoxyglucose PET/CT on the Management of Patients Suspected of Infective Endocarditis: The Prospective Multicenter TEPvENDO Study. Clin Infect Dis. 2021 Aug 2;73(3):393-403. doi: 10.1093/cid/ciaa666.
PMID: 32488236BACKGROUNDBoursier C, Duval X, Mahida B, Hoen B, Goehringer F, Selton-Suty C, Chevalier E, Roch V, Lamiral Z, Bourdon A, Piriou N, Pallardy A, Morel O, Rouzet F, Marie PY; AEPEI-TEPvENDO Study Group. Hypermetabolism of the spleen or bone marrow is an additional albeit indirect sign of infective endocarditis at FDG-PET. J Nucl Cardiol. 2021 Dec;28(6):2533-2542. doi: 10.1007/s12350-020-02050-2. Epub 2020 Feb 10.
PMID: 32043240BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Duval, Professor
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 11, 2014
Study Start
April 17, 2015
Primary Completion
April 1, 2016
Study Completion
January 1, 2017
Last Updated
August 8, 2025
Record last verified: 2017-07