Biodistribution and Dosimetry Evaluation of [124I]FIAU
This study has been completed.
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
First received: April 8, 2011
Last updated: June 26, 2013
Last verified: June 2013
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.
Prosthesis Related Infections
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The following are the main inclusion criteria for all subjects:
- 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
In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:
- Operative intervention planned in the 30 days following study enrollment
- Prosthetic joint implant in site for more than 3 months prior to enrollment
The following are the main exclusion criteria for all subjects:
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01337466
|University of Arkansas for Medical Sciences
|Little Rock, Arkansas, United States, 72205 |
|Sinai Hospital of Baltimore
|Baltimore, Maryland, United States, 21215 |
|North Shore long Island Jewish Medical Center
|Lake Success, New York, United States, 11042 |
BioMed Valley Discoveries, Inc
||Michael A Mont, MD
||Sinai Hospital of Baltimore
||BioMed Valley Discoveries, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2011
||June 26, 2013
||United States: Food and Drug Administration
Keywords provided by BioMed Valley Discoveries, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2016