Biodistribution and Dosimetry Evaluation of [124I]FIAU

NCT01337466 | Completed Phase 1

• 1 other identifier: BVD001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Prosthesis Related Infections

Keywords

Phase I; FIAU; Fialuridine; Biodistribution; Dosimetry; Prosthetic; Joint; Infection; PET-CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the safety and tolerability of [124I]FIAU

  28 +/- 2 days

Study Arms (1)

[124I]FIAU

EXPERIMENTAL

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

Radiation: [124I]FIAU

Interventions

[124I]FIAU RADIATION

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.

Also known as: Fialuridine

[124I]FIAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age \> 18 years
• Informed consent
• Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
• Women should be postmenopausal or surgically sterile
• Able to return for all study assessments
• Operative intervention planned in the 30 days following study enrollment
• Prosthetic joint implant in site for more than 3 months prior to enrollment

You may not qualify if:

• Unable to comply with study requirements
• Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
• Receipt of any antibiotic therapy in the 2 weeks preceding imaging
• 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
• Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
• Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
• 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 \[MELAS\]
• Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Pre-existing myopathy or neuropathy
• Abnormal liver function tests defined as alanine aminotransferase (ALT) \> the upper limit of normal (ULN), aspartate aminotransferase (AST) \> ULN, gamma glutamyl transferase (GGT) \> ULN
• Alcohol use \> 3 units per day in men or 2 units per day in women or active intravenous drug use
• Creatinine clearance \< 30 mL/min
• Body mass index \> 40
• Life expectancy \< 6 months
• Hypersensitivity to iodine

Sponsors & Collaborators

• BioMed Valley Discoveries, Inc: lead

Study Sites (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

North Shore long Island Jewish Medical Center

Lake Success, New York, 11042, United States

Location

MeSH Terms

Conditions

Prosthesis-Related Infections; Infections

Interventions

fialuridine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael A Mont, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 19, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (3)