Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis

NCT ID: NCT05446376

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2026-11-30

Brief Summary

CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2023 criteria, after 3 months of follow-up, by a panel of experts.

Detailed Description

Diagnosis of prosthetic valve infective endocarditis is challenging. It is based on the modified criteria of the European Society of Cardiology (ESC) 2023 which include clinical, microbiological and imaging data. 18F-fluorodeoxyglucose (18FDG) PET/CT is a major diagnostic criterion for prosthetic valve infective endocarditis. In practice, 18FGD-PET/CT is carried out as soon as possible in all patients having valve repair materials and suspected of infective endocarditis on material. According to studies, the sensitivity of 18FDG-PET/CT is around 80% for the diagnosis of infective endocarditis on a prosthetic valve. The use of 18FDG requires a low carbohydrate diet the day before the exam. Compliance with this condition is difficult to obtain, in diabetic patients. Without following these instructions, interpretation of the heart valves is difficult, and this can leed to false negatives. The use of an another radiopharmaceutical drug could avoid these problem. PET/CT with Gallium 68 citrate (68Ga-PET/CT) could reduce the number of false negatives while having similar specificity to 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.

The investigators therefore propose an exploratory study to assess the diagnostic performance of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2023 criteria, after 3 months of follow-up, by a panel of experts.

Patient suspected of infective endocarditis on prosthetic valves will be included.

The index test (68Ga-PET/CT) and the usual test (18FDG-PET/CT) will be performed in all participants. The 68Ga-PET/CT will be performed the day before, the same day or the next day after 18FDG-PET/CT.

. Both PET/CT scans will be interpreted independently by two experienced nuclear physicians, blinded to the final diagnosis.

Conditions

Infective Endocarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-citrate PET/CT

Group Type: EXPERIMENTAL

68Ga-citrate PET/CT

Intervention Type: DRUG

PET/CT Imaging with 68Ga-citrate PET/CT injection

Interventions

68Ga-citrate PET/CT

PET/CT Imaging with 68Ga-citrate PET/CT injection

Intervention Type: DRUG

Eligibility 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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carine GREIB, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Eric FRISON, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Carine GREIB, MD

Role: CONTACT

carine.greib@chu-bordeaux.fr

(0)5 57 65 64 83 ext. +33

Sandrine FOUCHET

Role: CONTACT

sandrine.fouchet@chu-bordeaux.fr

Facility Contacts

Carine GREIB, MD

Role: primary

carine.greib@chu-bordeaux.fr

(0)557656483 ext. +33

Sandrine FOUCHET

Role: backup

sandrine.fouchet@chu-bordeaux.fr

Other Identifiers

CHUBX 2020/49

Identifier Type: -

Identifier Source: org_study_id