Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Prosthetic valve infective endocarditis
Estimation of sensitivity of PET/CT with Gallium 68 citrate (68GaPET/CT) for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Bordeaux
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 22 Nov 2024 → ongoing
- Decision date (initial)
- 2024-07-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- University Hospital of Bordeaux
External identifiers
- EU CT number
- 2024-514331-24-00
- EudraCT number
- 2021-002898-26
- ClinicalTrials.gov
- NCT05446376
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Diagnosis
Estimation of sensitivity of PET/CT with Gallium 68 citrate (68GaPET/CT) for the diagnosis of prosthetic valve infective endocarditis in
patients suspected of infective endocarditis on prosthetic valve.
Secondary objectives 5
- 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.
Conditions and MedDRA coding
Prosthetic valve infective endocarditis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Experimental: 68Ga-citrate PET/CT All patients will have a 18FDG-PET/CT as part of the standard management strategy. For this research, a 68Ga-PET/CT will also be performed in all patients, the day before the 18FDG-PET/CT, the same day or the next day.
|
Not Applicable | Single | [{"id":155658,"code":4,"name":"Analyst"}] | Experimental: 68Ga-citrate PET/CT |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 6
- 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)
- Patient with cardiac surgery within 2 months of inclusion
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
Secondary endpoints 4
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11299232 · Product
- Active substance
- Gallium Citrate GA-68
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 150 MBq megabecquerel(s)
- Max total dose
- 150 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Bordeaux
- Sponsor organisation
- Centre Hospitalier Universitaire De Bordeaux
- Address
- Avenue De Magellan
- City
- Pessac
- Postcode
- 33600
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Coordinating Investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Coordinating Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-22 | 2024-11-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | France | Acceptable 2024-07-01
|
2024-07-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-04 | France | Acceptable 2024-07-01
|
2025-11-04 |