First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
详细描述
20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.
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
- •signed the informed consent
- •≥18 years old
- •confirmed as malignant solid tumor by histopathology or clinical judgment
- •Patients will undergo 18F-FDG PET/CT examination
排除标准
- •Known allergy to components of the investigational drug or its analogues
- •suspected to have a certain disease or condition that is not suitable for the study drug
- •Known pregnant or lactating women
研究组 & 干预措施
68Ga/64Cu-FAPI-XT117 PET/CT
Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.
干预措施: 2-4 mCi 68Ga/64Cu-FAPI-XT117 (Drug)
68Ga/64Cu-FAPI-XT117 PET/CT
Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.
干预措施: 4-6 mCi 68Ga/64Cu-FAPI-XT117 (Drug)
68Ga/64Cu-FAPI-XT117 PET/CT
Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.
干预措施: 6-8 mCi 68Ga/64Cu-FAPI-XT117 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 7 days following injection
Evaluation of Adverse Events (AE) Using CTCAE
次要结局
- Change in 'treatment strategy questionnaire'(2 months following injection)
- The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor(2 months following injection)
研究者
Ruimin Wang
chief of nuclear medicine department
Chinese PLA General Hospital