NCT01337466已完成1 期
Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Determine the biodistribution and dosimetry evaluation of [124I]FIAU
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
[124I]FIAU
Experimental
single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning
干预措施: [124I]FIAU (Radiation)
结局指标
主要结局
Determine the biodistribution and dosimetry evaluation of [124I]FIAU
时间窗: 72 hrs
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.
次要结局
- Evaluate the safety and tolerability of [124I]FIAU(28 +/- 2 days)
研究者
研究点 (3)
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