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
| NCT number | NCT02855190 |
| Other study ID # | 103-7226A |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | December 2018 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2018 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 99 Years |
| Eligibility |
Inclusion Criteria: 1. Patients with clinically-proved or -suspicious periprosthetic joint infection and treated with two-stage exchange arthroplasty 2. Age equals or more than 20 years old 3. Willing to sign the informed consent Exclusion Criteria: 1. 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. 2. Unable to give informed consent 3. Patient who is pregnant or lactating 4. Unwilling to use contraceptives during nuclide medicine examinations. 5. Allergy history to FDG or Ga68-citrate, significant abnormal lab data, and high risk to conduct examination after evaluations of PI. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chang Gung Memorial Hospital at Linkou | Taoyuan |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital |
Taiwan,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection | 3 years |