Biodistribution and Dosimetry Evaluation of [124I]FIAU

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

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 Overview

• Status: Completed
• Conditions: Prosthesis Related Infections
• Intervention / Treatment: Radiation: [124I]FIAU

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • New York
    • Lake Success, New York, United States, 11042
      • North Shore Long Island Jewish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

The following are the main inclusion criteria for all subjects:

1. Males or females age > 18 years
2. Informed consent
3. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
4. Women should be postmenopausal or surgically sterile
5. Able to return for all study assessments

In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:

1. Operative intervention planned in the 30 days following study enrollment
2. Prosthetic joint implant in site for more than 3 months prior to enrollment

The following are the main exclusion criteria for all subjects:

1. Unable to comply with study requirements
2. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
3. Receipt of any antibiotic therapy in the 2 weeks preceding imaging
4. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
5. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
6. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
7. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myoclonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS]
8. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
9. Pre-existing myopathy or neuropathy
10. Abnormal liver function tests defined as alanine aminotransferase (ALT) > the upper limit of normal (ULN), aspartate aminotransferase (AST) > ULN, gamma glutamyl transferase (GGT) > ULN
11. Alcohol use > 3 units per day in men or 2 units per day in women or active intravenous drug use
12. Creatinine clearance < 30 mL/min
13. Body mass index > 40
14. Life expectancy < 6 months
15. Hypersensitivity to iodine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [124I]FIAU; single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning	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.; Other Names: Fialuridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 +/- 2 days

Collaborators and Investigators

• Sponsor: BioMed Valley Discoveries, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 8, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (ESTIMATE): April 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 26, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Infection; Biodistribution; Phase I; Dosimetry; PET-CT; Joint; Prosthetic; FIAU; Fialuridine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Infections; Prosthesis-Related Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Fialuridine
• Other Study ID Numbers: BVD001