[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint

Study Overview
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Brief Summary
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This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.

Official Title
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Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint

Conditions
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Prosthetic Joint Infections

Intervention / Treatment
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* Radiation: [124I]FIAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age >18 years Ability to provide informed consent A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint Prosthetic joint implant that has been in site for more than 3 months prior to enrolment Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent Women must be either postmenopausal or surgically sterile Ability to return for all study assessments Clinically euthyroid, or on stable thyroid replacement therapy Exclusion Criteria: Subjects who are unable to comply with study requirements Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS]) Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN Creatinine clearance <30 mL/min Body mass that exceeds the rating of the CT table Hypersensitivity to iodine Any condition that would put the subject at reasonable risk in the opinion of the investigator

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [124I]FIAU<br>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning. | Radiation: [124I]FIAU<br>* This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.<br>* Other names: Fialuridine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the Sensitivity and Specificity of [124I]FIAU | The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used. | 30 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Safety and Tolerability of [124I]FIAU | Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry. | 30 +/- 2 days | 
| Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints | The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection. | 30 +/- 2 days | 
| Understand the Prevalence of Prosthetic Joint Infection | The trial failed primary outcome, and this secondary outcome was not analyzed | 30 +/- 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase II, FIAU, Fialuridine, Prosthetic, Joint, Infection, PET-CT