Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Standardized uptake value (SUV)
研究概览
简要总结
The primary objective of this study is to observe the distribution of 89Zr-CD147 and radiation dosimetry characteristics in patients with solid tumors. The secondary objective is to observe the pharmacokinetic characteristics of 89Zr-CD147 in patients with solid tumors. This study is a single-center, open-lable study, including 89Zr-CD147 1mCi±10%，89Zr-CD147 3mCi±10% and 89Zr-CD147 5mCi±10% dose group. The trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.
详细描述
Antibody based positron emission tomography (immuno-PET) imaging is of increasing importance to visualize and characterize tumor lesions. Additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
- •Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
- •Patients must have an ECOG performance status of 0-1;
- •Patients must have a life expectancy ≥ 12 weeks;
- •Patients must have adequate organ function:
- •White blood cell (WBC) count≥4.0x10^9/L or absolute neutrophil count (ANC) ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin≥ 90g/L ; thrombin time or Activated partial thromboplastin time≤1.5ULN; liver and renal function: Total bilirubin≤1.5ULN (upper limit of normal), Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN or ≤5ULN (subjects with liver metastasis), alkaline phosphatase (ALP)≤ 2.5ULN (if there is bone metastasis or liver metastasis ALP≤4.5ULN). Urea (BUN)≤1.5ULN, creatinine≤1.5ULN;
- •Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
- •For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.;
- •Patients must have the ability to understand and sign an approved ICF.
排除标准
- •There are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade III-IV), pulmonary embolism, deep venous thrombosis, Infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation;
- •Primary central nervous system tumor;
- •HBV DNA≥1000 copies/ml;
- •HCV-RNA≥1000 copies/ml;
- •People with positive antibodies to HIV or syphilis;
- •Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
- •Women who are pregnant, breastfeeding or planning pregnancy;
- •People who are known to be allergic to the study preparation or its auxiliary materials;
- •People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
- •Patients who cannot lie for half an hour;
- •Patients who are allergic to any component of the imaging agent or antibody;
- •Patients who cannot accept PET/CT imaging;
- •Situations that other researchers consider unsuitable to participate in the trial.
研究组 & 干预措施
89Zr-CD147 1mCi±10% 10mg dose group
The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.
干预措施: 89Zr-CD147 (Drug)
89Zr-CD147 3mCi±10% 10mg dose group
The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.
干预措施: 89Zr-CD147 (Drug)
89Zr-CD147 5mCi±10% 10mg dose group
The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.
干预措施: 89Zr-CD147 (Drug)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: Day 0-7
Standardized uptake value of tumor
standardized uptake value ratio (SUVR)
时间窗: Day 0-7
The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue
Radiation dose
时间窗: Day 0-7
Radiation dose of whole body and major tissues / organs of subjects after administration
次要结局
- Distribution (dL)(Day 0-7)
- Terminal Half Time (T1/2)(Day 0-7)
- Clearance (CL)(Day 0-7)
- Peak Plasma Concentration (Cmax)(Day 0-7)
- Area under the plasma concentration versus time curve (AUC)(Day 0-7)
研究者
Yue Chen
Director
The Affiliated Hospital Of Southwest Medical University