Infection and Inflammatory Reaction Due to Internal Joint Prosthesis Clinical Trial
Official title:
Pilot Comparative Study of PET/MR and PET/CT With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection
This is an open-labelled two-arm pilot comparative prospective study. All the subjects will
undergo image assessment in the two stages of exchange arthroplasty surgery. At the first
stage, each enrolled subject will receive both FDG and Ga68 citrate PET/CT scans before the
first operation for periprosthetic Joint Infection (PJI). Thus, the test results of FDG and
Ga68 for each individual can be obtained. After the first operation, the surgery/biopsy proof
can be obtained as the gold standard. The subjects those with PJI negative will complete the
process at the first stage.
And the second stage of this study will be based on the subjects with positive PJI from the
first operation. They will receive both FDG and Ga68 citrate PET/MR scans after antibiotic
bone cement was implanted. The sensitivity/accuracy of the two tracers for PET/MR can be
calculated and compared. This stage is aimed to answer whether PET/MR scan is a feasible
imaging tool to provide diagnostic information of infection control status after the
resection arthroplasty of hip/knee PJIs, especially with the implantation of antibiotic
loaded bone cement.
In the second stage, the investigators shift the imaging modality to PET/MR based on the
following reasons: (1) MRI itself has no radiation burden; (2) MRI provides more accurate
tissue contrast information and therefore better anatomic delineation; and (3) currently
there was no study indicating the existence of ABLC may hamper the interpretation of images.
The study duration is expected to be completed in a period of 3 year. It plans to enrol a
total of 40 evaluable subjects with suspicious. And we expect the PJI prevalence will be
around 75%, i.e. the anticipated number of subjects of true PJI is around 30. The sample size
and the prevanence is given based on the clinical availability and consideration.
The recruited subject subject with periprosthetic joint infection will undergo total four PET
scans at two different stages. At first stage, subsequent FDG PET/CT and Ga68 citrate PET/CT
scans on different two days will be arranged before infective prosthesis is removed. Eight to
twelve weeks after the 1st stage operation, patient will receive two subsequent PET/MR scans
using Ga-68 Citrate and FDG on different two days, respectively. The PET images will be
visually examined by a nuclear medicine physician and will be reported if any abnormal uptake
higher than background by their location and standard uptake value (SUV). The CT/MR images
will be reported by a radiologist using standard reading procedures, respectively. The
lesions on the PET scan will be correlated to the computed tomography and magnetic resonance
images, and the final sensitivity, specificity, and accuracy will be calculated according to
the histopathology results or composite clinical and laboratory data.
On the scan day using Ga68-Citrate, baseline electrocardiogram, complete blood count (CBC),
and biochemistry profiles including serum alanine transaminase (ALT) and creatinine (Cre)
level will be done prior to injection of the radio-pharmaceutical (Ga68-Citrate). Vital signs
will be measured before the scan beginning. After completing exam, the electrocardiogram and
vital signs will be measure again, and the subject will be released if there is no
discomfort. The subject will return to the clinic within 1 week after Ga68-citrate scan. CBC,
biochemistry profiles will be checked again for safety monitoring.
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