Biodistribution and Dosimetry Evaluation of [124I]FIAU

Phase 1

Completed

• Conditions: Prosthesis Related Infections
• Interventions: Radiation: [124I]FIAU

• Registration Number: NCT01337466
• Lead Sponsor: BioMed Valley Discoveries, Inc

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 Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-19
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[124I]FIAU	[124I]FIAU	single dose study of \[124I\]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning

Primary Outcome Measures

Name	Time	Method
Determine the biodistribution and dosimetry evaluation of [124I]FIAU	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of [124I]FIAU	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.

Trial Locations

Locations (3)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

North Shore long Island Jewish Medical Center; 🇺🇸 Lake Success, New York, United States