Prosthesis Related Infections Clinical Trial
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
| Verified date | June 2013 |
| Source | BioMed Valley Discoveries, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
| United States | North Shore long Island Jewish Medical Center | Lake Success | New York |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| BioMed Valley Discoveries, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the biodistribution and dosimetry evaluation of [124I]FIAU | 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. |
72 hrs | No |
| Secondary | Evaluate the safety and tolerability of [124I]FIAU | 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. | 28 +/- 2 days | Yes |