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

Phase 2

Recruiting

• Conditions: Prosthetic joint infection

• Registration Number: 2024-515781-13-00
• Lead Sponsor: Centre Hospitalier Universitaire De Bordeaux

Brief Summary

Estimation of diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

Patients aged over 18 years old

Patient adressed for the first time 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)

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

Primary Outcome Measures

Name	Time	Method
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).		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 Outcome Measures

Name	Time	Method
Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation		Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation
Diagnostic accuracy setting's assessment of marked polynuclear scintigraphy		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		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.		Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy.
Kind of discrepancy between the two exams		Kind of discrepancy between the two exams

Trial Locations

Locations (1)

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire De Bordeaux

🇫🇷Bordeaux, France

Frédéric-Antoine DAUCHY

Site contact

0556795536

frederic.dauchy@chu-bordeaux.fr