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Biodistribution and Dosimetry Evaluation of [124I]FIAU

NCT01337466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-06-27

No results posted yet for this study

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.

Conditions

  • Prosthesis Related Infections

Interventions

RADIATION

[124I]FIAU

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.

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    lead INDUSTRY

Principal Investigators

  • Michael A Mont, MD · Sinai Hospital of Baltimore

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337466 on ClinicalTrials.gov