Biodistribution and Dosimetry Evaluation of [124I]FIAU | NCT01337466

NCT01337466

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[124I]FIAU	Experimental	single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning	Radiation: [124I]FIAU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[124I]FIAU	Radiation	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States
Sinai Hospital of Baltimore

ID	Term
D016459	Prosthesis-Related Infections
D007239	Infections

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms