SPECT/CT Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI ([99mTc]Tc- HYNIC-FAPI) in Metastatic Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%).
研究概览
简要总结
The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.
详细描述
The primary objective are:
- To assess the distribution of [99mTc]Tc- HYNIC-FAPI in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc- HYNIC-FAPI.
- To study the safety and tolerability of the drug [99mTc]Tc- HYNIC-FAPI after a single injection in a diagnostic dosage.
The secondary objective are:
1. To compare the obtained [99mTc]Tc- HYNIC-FAPI SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in metastatic cancer patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of metastatic cancer with histological verification.
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 80 g/L
- •Platelets: > 50.0 x 10^9/L
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •Blood glucose level not more than 5.9 mmol/L
- •A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Active current autoimmune disease or history of autoimmune disease
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- •Known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
研究组 & 干预措施
Metastatic cancer patients
Metastatic cancer patients before starting chemotherapy.
干预措施: [99mTc]Tc-HYNIC-FAPI (Drug)
结局指标
主要结局
Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%).
时间窗: 2, 4, 6 and 24 hours after injection.
Whole-body \[99mTc\]Tc-HYNIC-FAPI uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.
SPECT/CT-based [99mTc]Tc-HYNIC-FAPI value in tumor lesions (counts and SUV)
时间窗: 2, 4 and 6 hours after injection.
99mTc\]Tc-HYNIC-FAPI uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts and SUV.
SPECT/CT -based [99mTc]Tc-HYNIC-FAPI background uptake value (counts and SUV).
时间窗: 2, 4 and 6 hours after injection.
Focal uptake of \[99mTc\]Tc-HYNIC-FAPI in the regions without pathological findings will be assessed with SPECT/CT and measured in counts and SUV.
Tumor-to-background ratio (SPECT/CT).
时间窗: 2, 4 and 6 hours after injection.
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-HYNIC-FAPI uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-HYNIC-FAPI uptake coinciding with the regions without pathological findings (counts).
次要结局
- Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal findings).(2, 4, 6 and 24 hours after injection.)
- Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings).(2, 4, 6 and 24 hours after injection.)
- Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with incidence of adverse events).(2, 4, 6 and 24 hours after injection.)
- Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with administration of concomitant medication).(2, 4, 6 and 24 hours after injection.)