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 ]
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