Biodistribution and Dosimetry Evaluation of [124I]FIAU

Study Overview
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Brief Summary
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This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of [124I]FIAU.

Official Title
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Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning

Conditions
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Prosthesis Related Infections

Intervention / Treatment
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* Radiation: [124I]FIAU


Participation Criteria
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Eligibility Criteria
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The following are the main inclusion criteria for all subjects: Males or females age > 18 years Informed consent Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator Women should be postmenopausal or surgically sterile Able to return for all study assessments In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection: Operative intervention planned in the 30 days following study enrollment Prosthetic joint implant in site for more than 3 months prior to enrollment The following are the main exclusion criteria for all subjects: Unable to comply with study requirements Indication in the opinion of the principal investigator for surgery within 48 hours of presentation. Receipt of any antibiotic therapy in the 2 weeks preceding imaging Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A) Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine) History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myoclonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS] Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Pre-existing myopathy or neuropathy Abnormal liver function tests defined as alanine aminotransferase (ALT) > the upper limit of normal (ULN), aspartate aminotransferase (AST) > ULN, gamma glutamyl transferase (GGT) > ULN Alcohol use > 3 units per day in men or 2 units per day in women or active intravenous drug use Creatinine clearance < 30 mL/min Body mass index > 40 Life expectancy < 6 months Hypersensitivity to iodine

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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Accepts Healthy Volunteers

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 healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning | Radiation: [124I]FIAU<br>* This is a single dose study of 2 mCi [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.<br>* Other names: Fialuridine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the biodistribution and dosimetry evaluation of [124I]FIAU | Subjects will be dosed with [124I]FIAU at Time 0 on Day 0, and a PET-CT scan will be conducted immediately after the injection. Imaging will be repeated at 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, and 72 hours after dosing. All images generated will be reviewed for biodistribution and dosimetry. | 72 hrs | 

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 and vital signs, clinical laboratory tests including LFTs, lactate, serum chemistry and CBC, physical examination, and 12-lead ECG. | 28 +/- 2 days | 

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