Biodistribution and Dosimetry Evaluation of [124I]FIAU

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