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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

April 8, 2011
June 26, 2013
December 2010
December 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01337466 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prosthesis Related Infections
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337466
BVD001
No
BioMed Valley Discoveries, Inc
BioMed Valley Discoveries, Inc
Not Provided
Principal Investigator: Michael A Mont, MD Sinai Hospital of Baltimore
BioMed Valley Discoveries, Inc
June 2013

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