Benefit of positons emission tomography / 68Gallium citrate tomodensitometry for artificial hip and knee chronic infection diagnosis

Phase 1

• Conditions: joint prosthesis infection; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2020-001906-41-FR
• Lead Sponsor: CHU DE BORDEAUX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

- Patients aged over 18 years old,
- Patient adressed to reference center for joint prosthesis infection (CRIOA, infectious diseases unit and orthopedic surgery unit) for suspicion of first episode of artificial 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified