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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
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.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
North Shore long Island Jewish Medical Center
Lake Success, New York, United States
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.
Time frame: 72 hrs
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.
Time frame: 28 +/- 2 days
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