Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biodistribution and Dosimetry Evaluation of [124I]FIAU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337466
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Tracking Information
First Submitted Date  ICMJE April 8, 2011
First Posted Date  ICMJE April 19, 2011
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Determine the biodistribution and dosimetry evaluation of [124I]FIAU [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Evaluate the safety and tolerability of [124I]FIAU [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biodistribution and Dosimetry Evaluation of [124I]FIAU
Official Title  ICMJE Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prosthesis Related Infections
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: [124I]FIAU
single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning
Intervention: Radiation: [124I]FIAU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2011)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337466
Other Study ID Numbers  ICMJE BVD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioMed Valley Discoveries, Inc
Study Sponsor  ICMJE BioMed Valley Discoveries, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael A Mont, MD Sinai Hospital of Baltimore
PRS Account BioMed Valley Discoveries, Inc
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP