Contribution of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis

Contribution of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis - CiGal-EI-TEP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002898-26-FR

Enrollment

Registered

2022-04-27

Start date

2022-07-01

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Prosthetic valve infective endocarditis

Interventions

Product Name: [68Ga]Ga-citrate Product Code: [68Ga]Ga-citrate Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patient (over 18 years old); - Patient with a prosthetic heart valve; - Patient suspected of infective endocarditis (on clinical and/or microbiological and/or imaging data); - Patient whose history is discussed in the multidisciplinary meeting dedicated to endocarditis; - Patient beneficiary of a social security scheme; - Free, informed and written consent signed by the participant and the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - pregnant or breastfeeding women; - women of childbearing potential not using effective contraception; - patients referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent); - subject in a period of relative exclusion due to another protocol; - known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients).

Design outcomes

Primary

Measure	Time frame
Main Objective: Estimation of sensitivity of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.;Secondary Objective: - Estimation of other diagnostic accuracy parameters of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Estimation of the inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Comparaison of the sensitivity and specificity of 68Ga-PET/CT to those of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve. - Estimation of the contribution of 68Ga-PET/CT in the extension assessment at the thoraco-abdomino-pelvic level. - Estimation of the contribution of 68Ga-PET/CT in the search for the portal of entry.;Primary end point(s): Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve. ;Timepoint(s) of evaluation of this end point: 3 months after baseline	—

Measure

Time frame

Main Objective: Estimation of sensitivity of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.;Secondary Objective: - Estimation of other diagnostic accuracy parameters of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Estimation of the inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Comparaison of the sensitivity and specificity of 68Ga-PET/CT to those of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve. - Estimation of the contribution of 68Ga-PET/CT in the extension assessment at the thoraco-abdomino-pelvic level. - Estimation of the contribution of 68Ga-PET/CT in the search for the portal of entry.;Primary end point(s): Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve. ;Timepoint(s) of evaluation of this end point: 3 months after baseline

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Secondary

Measure	Time frame
Secondary end point(s): - Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Cohen’s kappa for inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve - Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve. - Discrepancies between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry.;Timepoint(s) of evaluation of this end point: 3 months after baseline	—

Measure

Time frame

Secondary end point(s): - Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve. - Cohen’s kappa for inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve - Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve. - Discrepancies between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry.;Timepoint(s) of evaluation of this end point: 3 months after baseline

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Countries

France

Contacts

Public ContactResponsable d'Etudes Cliniques

CHU DE BORDEAUX

laetitia.lacaze-buzy@chu-bordeaux.fr05 57 82 11 34+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026