Early Prediction of Tumor Response to Treatment: Translation of 99mTc-Duramycin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Determine the biodistribution of [99mTc]Duramycin.
研究概览
简要总结
Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of [99mTc]Duramycin.
详细描述
Monocenter, prospective microdosing study in healthy volunteers. Healthy volunteers will undergo a [99mTc]Duramycin whole-body planar and abdominal SPECT scan at different time points after one iv injection of the radiotracer (1 h, 2h, 3h, 6h and 24h), while vital signs, urine and faces analysis will be checked. Blood samples will be taken at 12 different time points: 9 blood samples for dosimetry study and 3 blood samples will be subjected to clinical laboratory chemistry (renal and liver function chemistry, hematology, and blood coagulation parameters).
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
- •Males (n=4) or females (n=4) age 18 years or older
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Ability to give study-specific written informed consent.
排除标准
- •Pregnant or lactating females (positive pregnancy test)
- •Metal implants (e.g. pacemakers, osteosynthesis material)
- •Body weight > 100 kg
- •Severe claustrophobia
- •Abnormal kidney or liver function tests
- •Unable to comply with study requirements
研究组 & 干预措施
99mTC-duramycin
single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points
干预措施: 99mTc-Duramycin (Drug)
结局指标
主要结局
Determine the biodistribution of [99mTc]Duramycin.
时间窗: 24 hours
Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing. All images generated will be reviewed for biodistribution.
Determine the dosimetry evaluation of [99mTc]Duramycin.
时间窗: 24 hours
Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing. All images generated will be reviewed for dosimetry.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"(72 hours)