Clinical trial NCT01337466: Biodistribution and Dosimetry Evaluation of [124I]FIAU
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prosthesis Related Infections
Keywords: Phase I
FIAU
Fialuridine
Biodistribution
Dosimetry
Prosthetic
Joint
Infection
PET-CT
Lead sponsor: BioMed Valley Discoveries, Inc
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Determine the biodistribution and dosimetry evaluation of [124I]FIAU
timeFrame: 72 hrs
Secondary outcomes:
measure: Evaluate the safety and tolerability of [124I]FIAU
timeFrame: 28 +/- 2 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Lake Success
country: United States
facility: North Shore long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Sinai Hospital of Baltimore
name: Michael A Mont, MD
role: PRINCIPAL_INVESTIGATOR
References: