NCT05609552已完成不适用
Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Biodistribution of 18F-pretomanid
研究概览
简要总结
This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine multi-compartment, noninvasive determination of pretomanid PK in TB patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Male or female ≥18 years of age at the time of consent and imaging
- •Healthy subjects OR Subjects with confirmed tuberculosis OR high suspicion of active tuberculosis by treating physician.
- •For TB patients: Imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement.
- •For TB patients: After TB diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting TB treatment.
- •Subject is willing to give written informed consent. Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures.
- •Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator.
- •Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration.
- •Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study-related procedures.
排除标准
- •Inadequate venous access
- •Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study
结局指标
主要结局
Biodistribution of 18F-pretomanid
时间窗: Up to 4 hours
Exposures in infected sites (pneumonia, cavitary lesions, etc.) will compared with the uninfected compartments. Standard units such as area under the curve (AUC) or AUC ratios will be utilized.
次要结局
未报告次要终点
研究者
研究点 (1)
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