Biodistribution and Dosimetry Evaluation of [124I]FIAU

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier:
NCT01337466
First received: April 8, 2011
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Prosthesis Related Infections
Radiation: [124I]FIAU
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by BioMed Valley Discoveries, Inc:

Primary Outcome Measures:
  • Determine the biodistribution and dosimetry evaluation of [124I]FIAU [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

    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:
  • Evaluate the safety and tolerability of [124I]FIAU [ Time Frame: 28 +/- 2 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: December 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Fialuridine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337466

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, New York
North Shore long Island Jewish Medical Center
Lake Success, New York, United States, 11042
Sponsors and Collaborators
BioMed Valley Discoveries, Inc
Investigators
Principal Investigator: Michael A Mont, MD Sinai Hospital of Baltimore
  More Information

No publications provided

Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01337466     History of Changes
Other Study ID Numbers: BVD001
Study First Received: April 8, 2011
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMed Valley Discoveries, Inc:
Phase I
FIAU
Fialuridine
Biodistribution
Dosimetry
Prosthetic
Joint
Infection
PET-CT

Additional relevant MeSH terms:
Prosthesis-Related Infections
Infection
Postoperative Complications
Pathologic Processes
Fialuridine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014