An interventional study of 68Ga-citrate and 18F-FDG PET scans in Infection and Inflammatory Reaction Due to Internal Joint Prosthesis, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-06-21.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic
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.
6,701 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.
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Exclusion Criteria:
The recruited subject with surgery/pathology proved 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. For the subject without surgery/pathology proved infection, PET/MR scans will NOT be applied.
Other: 68Ga-citrate and 18F-FDG PET scans
68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations
sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection
Time frame: 3 years
Plan to share: Yes
Started Jan 2016 (actual). Primary completion is estimated for Jul 2018, 30 months after the start.
Of 730 non-industry interventional studies with no phase under Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 30 months is above that.
Counting every sponsor, half of 807 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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