A Phase 2 interventional study of 68Ga-citrate PET/CT in Prosthetic Joint Infection, sponsored by University Hospital, Bordeaux. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Diagnostic
Diagnosis of chronic prosthetic joint infection (PJI) can be difficult. 68Ga-citrate Positron Emission Tomography/Computed Tomography (PET/CT) has been recently developed and has many advantages such as high resolution and low radiation exposure. To date, 68Ga-citrate PET/CT has not been specifically assessed in prosthetic joint infection. In this prospective study, patients referred for a suspected PJI will benefit from both a 68Ga-citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. The primary outcome is the assessment of the 68Ga-citrate PET/CT accuracy for the diagnosis of chronic prosthetic hip or knee infection.
Prosthetic joint infection (PJI) is a serious and rare complication of orthopedic surgery. Diagnosis is based on precise criteria (MSIS criteria Musculoskeletal Infection Society). However, diagnosis can be difficult, in particular when the infection is present for more than one month. One of the usual exams is bone scintigraphy and 99mTc-HMPAO-labelled leukocyte scintigraphy. This imaging allows an accurate assessment but it has some limitations since it requires ex vivo isolation and marking of patient's leukocytes and repeated acquisition for 24 hours. 68Gallium-citrate positron emission tomography/computed tomography (68Ga-citrate PET/CT) has been recently developed. 68Ga-citrate PET/CT is innovative compared to [18F]fluorodeoxyglucose PET/CT (18F-FDG PET/CT) and has many advantages: high resolution, realization in only two hours, short radioactive period and no handling of patient's leukocytes. Furthermore, preliminary data indicate that 68Ga-citrate is picked up by immune cells, which makes this exam inflammation-selective. To date, 68Ga-citrate PET/CT has not been specifically assessed in PJI, it is the objective of the present study:
Prospective study using 68Ga- citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. Patients referred for a suspected PJI and with a positive bone scintigraphy will be prospectively enrolled. After information and signature of informed consent, patients will benefit from a 68Ga citrate PET/CT, in addition to leukocyte scintigraphy in a two-week period. Both images will be anonymized and interpreted by two independent nuclear physicians.
Final PJI diagnosis is based on reference criteria (MSIS) to ensure diagnosis during the standardized medical follow-up. Patients will be followed until 12 months after the leukocyte scintigraphy.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 35 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Diagnostic Test: 68Ga-citrate PET/CT
PET/CT Imaging with 68Ga-citrate PET/CT injection
Diagnostic accuracy of 68Ga citrate PET / CT scan CT for chronic prosthetic hip or knee infection
Sensibility, specificity, positive and negative predictive value. Index test : 68Ga citrate PET / CT scan CT at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion. After 12 months, participants will be considered free of chronic prosthetic hip or knee infection.
Time frame: Up to 12 months after baseline (Day 0)
Diagnostic accuracy of quantitative 68Ga citrate PET / CT scan for chronic prosthetic hip or knee infection
Area under ROC curve (AUROC) for SUVmax ROI and SUVmax ROI/SVmax liver region ratio measured at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion.
Time frame: Up to 12 months after baseline (Day 0)
Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation
Intraclass correlation coefficient and/or Cohen's Kappa.
Time frame: Up to 12 months after baseline (Day 0)
Diagnostic accuracy of leukocyte scintigraphy for chronic prosthetic hip or knee infection
Sensibility, specificity, positive and negative predictive values. Index test : leukocytes scintigraphy at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion.
Time frame: Up to 12 months after baseline (Day 0)
Diagnosis accuracy of 68Ga-citrate PET/CT and leukocytes scintigraphy for chronic prosthetic hip or knee infection in the following sub-groups: prosthetic knee or hip infection.
Sensibility, specificity, positive and negative predictive values, in each subgroup. Index test : 68Ga citrate PET / CT scan CT at inclusion. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion. After 12 months, participants will be considered free of chronic prosthetic hip or knee infection.
Time frame: Up to 12 months after baseline (Day 0)
Comparison of diagnostic accuracy of 68Ga-PET/CT and leukocytes scintigraphy for chronic prosthetic hip or knee infection
Sensibility, specificity, positive and negative predictive values. Reference test : Musculoskeletal Infection Society (MSIS) criteria assessed up to 12 months after inclusion. Index test : 68Ga citrate PET / CT scan CT at inclusion and leukocytes scintigraphy at inclusion.
Time frame: Up to 12 months after baseline (Day 0)
Plan to share: No
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University Hospital, Bordeaux