Infective EndocarditisPhase 2CiGal-EI-TEPNCT05446376
Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
A Phase 2 study testing 68Ga-citrate PET/CT in people with Infective Endocarditis, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- 68Ga-citrate PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2024to 6 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 68Ga-citrate PET/CT
- Keywords
- prosthetic valve, PET/CT, Gallium 68, diagnosis, infective endocarditis
- Medical subject headings
- Endocarditis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-citrate PET/CTDrug
PET/CT Imaging with 68Ga-citrate PET/CT injection
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-citrate PET/CT | Experimental | Not described Receives: Drug: 68Ga-citrate PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 3 months after baseline (Day 0)
Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation
Intraclass correlation coefficient and/or Cohen's Kappa.
Measured: 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.
Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.
Measured: 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
Cohen's Kappa
Measured: 3 months after baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start22 Nov 2024
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine GREIB, MD, Principal investigator, University Hospital, BordeauxEric FRISON, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446376
- Sponsor's protocol ID
- CHUBX 2020/49
- Other IDs
- 2021-002898-26, 2024-514331-24-00
- Acronym
- CiGal-EI-TEP
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2022
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05446376
- Acronym / sponsor ID
- CiGal-EI-TEP / CHUBX 2020/49
- Conditions
- Infective Endocarditis
- Keywords
- prosthetic valve, PET/CT, Gallium 68, diagnosis, infective endocarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 6 Jul 2022 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-citrate PET/CT | Experimental | Drug: 68Ga-citrate PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| 68Ga-citrate PET/CTPET/CT Imaging with 68Ga-citrate PET/CT injection | Drug | 68Ga-citrate PET/CT |
Primary outcome
Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
Time frame: 3 months after baseline (Day 0)
The final diagnosis of infective endocarditis is established according to the ESC 2023 criteria (assessed at 3 months by a panel of experts).
4 secondary outcomes
Diagnostic accuracy of 68Ga citrate PET / CT scan CT for prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
Time frame: 3 months after baseline (Day 0)
Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation
Time frame: 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.
Time frame: 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
Time frame: 3 months after baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carine GREIB, MD principal investigator
University Hospital, Bordeaux
Eric FRISON, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-citrate PET/CT in people with Infective Endocarditis, run by University Hospital, Bordeaux 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve (time frame: 3 months after baseline (Day 0)). 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 27 Aug 2026.