Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
35
Countries
1
Sites
1
Prosthetic joint infection
Estimation of diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection
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
- 2 Feb 2022 → ongoing
- Decision date (initial)
- 2024-08-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Appel d’Offre Interne du CHU de Bordeaux (AOI) 2019
External identifiers
- EU CT number
- 2024-515781-13-00
- EudraCT number
- 2020-001906-41
- ClinicalTrials.gov
- NCT04938193
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Estimation of diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection
Secondary objectives 4
- Estimation of the inter-observer reproducibility of the PET / CT reading at 68Ga citrate
- Estimation of the diagnostic accuracy of the multinuclear scintigraphy in the diagnosis in chronic hip or knee joint prosthesis infection.
- Estimation of the diagnostic accuracy of PET / CT with citrate 68Ga and scintigraphy with polymorphonuclear in the 2 patient subpopulations: knee or hip infection
- Comparison of the diagnostic accuracy of PET / CT with 68Ga citrate to that of scintigraphy using polymorphonuclear drugs in the diagnosis of chronic hip or knee joint prosthesis infection.
Conditions and MedDRA coding
Prosthetic joint infection
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | 68Ga-citrate PET/CT Réalisation d'un examen d'imagerie TEP/TDM au citrate Gallium 68
|
Not Applicable | Single | [{"id":135464,"code":4,"name":"Analyst"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients aged over 18 years old
- Patient with first complete care at the South-Western France referral center for complex bone and joint infections (Crioac GSO, infectious diseases and orthopedic surgery units) for a suspicion of prosthetic hip or knee infection
- Suspicion of artificial joint infection starting at least one month before evaluation.
- Patient for who routine diagnosis includes screaning by both bone scintigraphy and polynuclear scintigraphy.
- Patient with positive bone scintigraphy
- Being affiliated to a health insurance system
- Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
Exclusion criteria 8
- Patient with progressive cancer
- Patient with negative bone scintigraphy
- Patient who cannot stop antibiotic for 14 days because of his state of health
- Pregnant or breastfeeding women
- Women of childbearing age but not using effective means of contraception
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
- Subject in relative exclusion period from another protocol
- Known contraindications to PET exam with radio tracer injection (hypersensitivity to radiopharmaceutical and/or to excipients)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Diagnostic accuracy setting's assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value).
Secondary endpoints 5
- Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation
- Diagnostic accuracy setting's assessment of marked polynuclear scintigraphy
- Diagnosis accuracy's assessment of 68Ga citrate PET/TDM and marked polynuclear scintigraphy for both under-populations: artificial knee or hip infection
- Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy.
- Kind of discrepancy between the two exams
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
- INTRAVENOUS USE
- 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
- 12 Rue Dubernat, Cs 91286 Cs 91286
- City
- Talence
- Postcode
- 33400
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 35 | 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 | 2022-02-02 | 2022-02-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515781-13-00 public | 4.0 |
| Protocol (for publication) | D2_Protocol modification 2024-515781-13-00 | 1.0 |
| Recruitment arrangements (for publication) | Document not required | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed consent procedure | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient TC | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patients | 4.0 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2024-515781-13-00 public | 4.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | France | Acceptable 2024-08-12
|
2024-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-30 | France | Acceptable 2025-08-06
|
2025-08-25 |