GALLIUM CITRATE GA-68 for Prosthetic joint infection

Inclusion criteria

• {"criterion_text":"- Patients aged over 18 years old\n- 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\n- Suspicion of artificial joint infection starting at least one month before evaluation.\n- Patient for who routine diagnosis includes screaning by both bone scintigraphy and polynuclear scintigraphy.\n- Patient with positive bone scintigraphy\n- Being affiliated to a health insurance system\n- Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)"}

Exclusion criteria

• {"criterion_text":"- Patient with progressive cancer\n- Patient with negative bone scintigraphy\n- Patient who cannot stop antibiotic for 14 days because of his state of health\n- Pregnant or breastfeeding women\n- Women of childbearing age but not using effective means of contraception\n- 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)\n- Subject in relative exclusion period from another protocol\n- Known contraindications to PET exam with radio tracer injection (hypersensitivity to radiopharmaceutical and/or to excipients)"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Assessment of diagnostic accuracy measured by sensitivity, specificity, positive predictive value and negative predictive value for 68Ga citrate PET/CT in diagnosis of chronic hip or knee prosthetic infection."}

Secondary endpoints

• {"endpoint_text":"- Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation\n- Diagnostic accuracy setting's assessment of marked polynuclear scintigraphy\n- Diagnosis accuracy's assessment of 68Ga citrate PET/TDM and marked polynuclear scintigraphy for both under-populations: artificial knee or hip infection\n- Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy.\n- Kind of discrepancy between the two exams","definition_or_measurement_approach":"Inter-observer reproducibility assessed for PET/CT read; diagnostic accuracy of polymorphonuclear (leucocyte) scintigraphy assessed (presumably by sensitivity/specificity metrics); subgroup analyses for knee vs hip; direct comparison of diagnostic accuracy metrics between 68Ga-citrate PET/CT and marked polynuclear scintigraphy; description and analysis of discordances between the two imaging modalities."}

France

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

417

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France