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

NCT05446376 | Completed Phase 2

• 3 other identifiers: CHUBX 2020/492021-002898-262024-514331-24-00
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis

Keywords

prosthetic valve; PET/CT; Gallium 68; diagnosis; infective endocarditis

Outcome Measures

Primary Outcomes (1)

• Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve

  The final diagnosis of infective endocarditis is established according to the ESC 2023 criteria (assessed at 3 months by a panel of experts).

  3 months after baseline (Day 0)

Secondary Outcomes (4)

• Diagnostic accuracy of 68Ga citrate PET / CT scan CT for prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve

  3 months after baseline (Day 0)

• Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation

  3 months after baseline (Day 0)

• Comparison of diagnostic accuracy of 68Ga-PET/CT and 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.

  3 months after baseline (Day 0)

• o Agreement 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

  3 months after baseline (Day 0)

Study Arms (1)

68Ga-citrate PET/CT

EXPERIMENTAL

Drug: 68Ga-citrate PET/CT

Interventions

68Ga-citrate PET/CT DRUG

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

68Ga-citrate PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Endocarditis; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carine GREIB, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Eric FRISON, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: November 22, 2024
• Primary Completion: May 6, 2026
• Study Completion: May 6, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)