Novel Gallium 68 Citrate in Orthopedic Infections

Study Overview
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Brief Summary
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In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.

Official Title
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Novel Gallium 68 Citrate in Orthopedic Infections

Conditions
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Joint Prosthesis

Intervention / Treatment
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* Drug: 68-Gallium citrate PET/CT scan
* Drug: 18F FDG PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 6 months after hip replacement with complaint of joint pain. Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening). Pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening. Exclusion Criteria: Inability to consent Pregnancy or known or suspected hypersensitivity to metals or gallium Joint replacement for any reason other than primary or secondary osteoarthritis Prior surgical therapy for prosthesis failure after initial hospital discharge Active inflammatory/infectious process at any location other than prosthetic joint (Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Same patients are scanned with two radiotracers within 24-48 hours. Results of the two scans are compared against each other.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Gallium-citrate<br>This arm, undergoing the 68-Gallium citrate PET/CT scan intervention, includes the PET/CT scans performed with 68Gallium-citrate radiotracer. Note that same patients scanned with different radiotracers serve in both arms. | Drug: 68-Gallium citrate PET/CT scan<br>* After establishment of an intravenous access, approximately 5 mCi of 68Ga-citrate (Zevacor Molecular, Somerset, NJ, USA) will be administered intravenously. Whole body PET/CT scan will be performed after 60 minutes of uptake phase.<br>|
| Experimental: 18F-FDG<br>This arm, undergoing the 18F FDG PET/CT scan intervention, includes the PET/CT scans performed with 18F-FDG tracer. Note that same patients scanned with different radiotracers serve in both arms. | Drug: 18F FDG PET/CT scan<br>* Subjects will undergo FDG PET/CT scan using the same imaging parameters either on the same day or within the next 24-48 hours. The subjects will be requested to fast for a minimum of 4 h prior to PET acquisition. After confirmation of a blood glucose level ≤200 mg/dl, technologists will establish the intravenous access and the subject will receive approximately 10 mCi of 18F-FDG (Zevacor Molecular, Somerset, NJ, USA) intravenously. The subject will be placed in uptake room for 60 minutes to allow for optimal localization of the compound. The subjects will be requested to void prior to administration of 18FDG and again prior to image acquisition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis | The radiotracer uptake in SUV units is measured in different Gruen zones around the prosthesis and normalized by that of the liver. The values of the two scans will be compared against each other for all patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard. | Using the surgical histology and tissue culture as the gold standard, sensitivity and specificity of both techniques will be calculated. The aim is determine which modality has more accuracy to differentiate septic prosthesis failure from aseptic entities. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, 68Gallium Citrate, Orthopedic Hardware infection