NCT07822347Enrolling By Invitation1 期
Exploratory Study of a Novel Dual Target Molecular Probe NI-FAPI-04 for Intra Irradiation Therapy of Hypoxic and Fibroblast Activation Protein Related Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years old
- •Obtain pathological results through surgery or biopsy
- •Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria)
- •Expected survival time greater than 6 months
- •Baseline [68Ga] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions
- •Informed consent and the ability to accept follow-up
- •Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L
- •Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis<5 × ULN; Albumin>3.0 g/dL; Total bilirubin ≤ 1.5 × ULN
- •Renal function: creatinine clearance rate ≥ 50 mL/min
- •Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)<2 × ULN
排除标准
- •Pregnant and lactating female patients
- •Individuals who fear confinement or radiation
- •Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks
- •Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months
- •Individuals who have experienced severe allergic reactions to the components of [177Lu] Lu-NI-FAPI-04 injection in the past
- •Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (except for those who participated in observational, non interventional clinical studies, or are currently in the follow-up period of interventional clinical studies)
- •Patients who are difficult to receive further diagnosis and treatment due to severe illness
研究组 & 干预措施
NI-FAPI group
Experimental
Injection of [177Lu]Lu-NI-FAPI
干预措施: Injection of 177Lu-NI-FAPI (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 6-8 weeks after administration
According to CTCAE v5.0, the number of patients who experienced adverse events was counted
次要结局
- Visual analysis of PET images before and after treatment(6-8 weeks after administration)
- The size of the lesion before and after treatment(6-8 weeks after administration)
- The degree of uptake of the lesion before and after treatment(6-8 weeks after administration)
研究者
Zhaohui Zhu
Chief physician
Peking Union Medical College Hospital
研究点 (1)
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