[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic
 imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
Inclusion Criteria:

 1. Male and female patients >/= 18 years on the day of signing consent.

 2. A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or
 receipt of antidiabetic medication at time of enrollment.

 3. Ability to provide informed consent

 4. An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and
 sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with
 PEDIS grade 4 infections may be included if they are sufficiently stable.

 5. For females of childbearing potential, a negative urine pregnancy test on the day of
 dosing.

 6. For females of childbearing potential, a willingness to use 2 methods of contraception
 for 30 days after receiving [124I]FIAU.

 7. Ability to return for all study assessments.

 8. Clinically euthyroid, or on stable thyroid replacement therapy.

 Exclusion Criteria:

 1. Patients who ar unable to comply with study requirements.

 2. Indication, in the opinion of the principal Investigator for urgent surgery that would
 preclude the time needed for PET-CT scanning, or clinical instability that precludes
 PET-CT scanning.

 3. History of an inherited mitochondrial disorder (eg. 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])

 4. Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate
 aminotransferase (AST) >5x ULN.

 5. Body mass that exceeds the rating of the CT table.

 6. Hypersensitivity to iodine.

 7. Pregnant or breast-feeding.

 8. Any condition that would put the patient at unreasonable risk in the opinion of the
 Investigator.