Comparative Study With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Peri… (NCT02855190) | Clinical Trial Compass
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Comparative Study With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection
Taiwan30 participantsStarted 2016-01
Plain-language summary
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.
Who can participate
Age range
20 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with clinically-proved or -suspicious periprosthetic joint infection and treated with two-stage exchange arthroplasty
. Age equals or more than 20 years old
. Willing to sign the informed consent
Exclusion criteria
. Unable to tolerate PET/MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), claustrophobia, unable to lie still, allergy to medium contrast.
. Unable to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection