Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET
研究概览
简要总结
The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging of tissue factor (TF) expression. The tracer has the potential of identifying tumors with high levels of TF expression, which is expected to correlate with tumor aggression and prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic agent for identifying patients eligible for TF directed therapies.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and 4 hours post-injection).
详细描述
The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging of tissue factor (TF) expression. The tracer has the potential of identifying tumors with high levels of TF expression, which is expected to correlate with tumor aggression and prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic agent for identifying patients eligible for TF directed therapies.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and 4 hours post-injection).
The primary end points are safety, biodistribution and dosimetry of 18F-ASIS. In addition, the quantitative uptake of 18F-ASIS will be compared to the expression of TF measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
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
- 否
入选标准
- •Diagnosed with breast, lung, pancreatic, cervix or ovarian cancer
- •Capable of understanding the patient information in Danish and giving full informed consent
排除标准
- •Pregnancy
- •Breast-feeding
- •Weight above 140 kg
- •History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-ASIS
研究组 & 干预措施
18F-ASIS PET
One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection
干预措施: Injection of 18F-ASIS (Drug)
18F-ASIS PET
One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection
干预措施: PET/CT scan (Other)
结局指标
主要结局
1.Biodistribution of the radiotracer 18F-ASIS estimated by PET
时间窗: 4 hours
The biodistribution of the 18F-ASIS radiotracer estimated from the standardized uptake values (SUV) of the major organs obtained from the patient's repeated PET imaging with the radiotracer 18F-ASIS
2.Dosimetry of the radiotracer 18F-ASIS estimated by PET
时间窗: 4 hours
Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 18F-ASIS
3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 48 hours
The safety of 18F-ASIS PET as measured by the number of participants with adverse events within 48 hours following the 18F-ASIS PET assessed by CTCAE v5.0
次要结局
- 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue(4 hours)
研究者
Mathias Dyrberg Loft
Principal Investigator, MD
Rigshospitalet, Denmark