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临床试验 NCT07172503 针对结直肠癌，Gastric Cancer (GC)，胰腺癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors 56
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临床试验NCT07172503是一项针对结直肠癌，Gastric Cancer (GC)，胰腺癌的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年10月1日开始，预计招募56名患者。该研究由Union Hospital, Tongji Medical College, Huazhong University of Science and Technology主导，计划于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月15日。
简要概括
This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed colorectal cancer, gastric cancer, pancreatic cancer and other malignant tumors with high expression of GPA33 will be recruited for PET/MR or PET/CT imaging targeting a GPA33-specific probe (in the case of \[68Ga\]Ga-NOTA-GPA33 nanobody) , to observe the reaction of volunteers and patients after injection of drugs...显示更多
详细描述
Malignant tumors are one of the major diseases leading to death worldwide, and their high incidence and mortality rates pose a serious threat to human health. According to the World Health Organization (WHO), there will be about 19.3 million new cancer cases and 10 million deaths globally in 2020, with a significant increase in the incidence of malignant tumors such as colorectal and gastric cancers in particular. Ea...显示更多
官方标题
Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors
疾病
结直肠癌Gastric Cancer (GC)胰腺癌其他研究标识符
- XLan-0907
NCT编号
实际开始日期
2025-10-01
最近更新发布
2025-09-15
预计完成日期
2026-12-31
计划入组人数
56
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
主要目的
诊断
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性PET imaging targeting GPA33 in malignant tumors Determine if targeting GPA33 PET is safe and effective method for imaging of malignant tumors. | 68Ga-NOTA-GPA33 nanobody To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed colorectal cancer, gastric cancer, pancreatic cancer and other malignant tumors with high GPA33 expression and healthy volunteers, using specific positron imaging agents target GPA33(in the case of \[68Ga\]Ga-NOTA-GPA33 nanobody) , to achieve the following purposes: Patients with malignant tumors: for diagnosis and...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Visual and standardized uptake values assessment of lesions and biodistribution | At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPA33 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage. | 1 year |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Radioactivity in the blood and urine samples | Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection. | 1 year |
Pathological sections of tumour tissue | The excised tumour tissue was taken for immunohistochemistry to verify its GPA33 expression | 1 year |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
Each subject must meet all enrollment criteria to be eligible to participate in the study:
- 1: The subject or his/her legal representative is able to sign and date the informed consent form;
- 2: A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
- 3: Adult patients or healthy volunteers (aged 18 or above) of either sex;
- 4: Patients with clinically suspected or confirmed malignant tumors such as colorectal cancer, gastric cancer, pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
- 5: Consistent with the results of specific laboratory tests;
- 6: Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
- 7: Other set entry criteria.
All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
- 1: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
- 2: Having other comorbidities;
- 3: Patients with known hypersensitivity to GPA33 nanobody developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
- 4: Have a history of comorbid drug use;
- 5: Patients considered by the investigator to have poor compliance;
- 6: Patients during pregnancy or lactation;
- 7: Persons with other factors that make participation in this test inappropriate.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology研究中心联系人
联系人: Xiaoli Lan, PhD, 0086-027-83692633, [email protected]
1 位于 1 个国家/地区的研究中心
Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China
Xiaoli Lan, PhD, 联系人, +86-027-83692633, [email protected]