Clinical Trial: Biodistribution and Dosimetry Evaluation of [124I]FIAU

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: BioMed Valley Discoveries, Inc

Current Primary Outcome: Determine the biodistribution and dosimetry evaluation of [124I]FIAU [ Time Frame: 72 hrs ]

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.



Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the safety and tolerability of [124I]FIAU [ Time Frame: 28 +/- 2 days ]

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.


Original Secondary Outcome: Same as current

Information By: BioMed Valley Discoveries, Inc

Dates:
Date Received: April 8, 2011
Date Started: December 2010
Date Completion:
Last Updated: June 26, 2013
Last Verified: June 2013