跳至主要内容
临床试验/NCT06684028
NCT06684028招募中不适用

PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors

Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues

研究概览

简要总结

To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

详细描述

PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
  • Age 18-85 years old, male or female;
  • Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
  • ECOG score is 0-3 points;

排除标准

  • Patients with a history or allergic constitution to any component of the developer, including alcohol;
  • pregnant or lactating women;
  • Patients with mental illness or related history;
  • Patients who cannot or cannot undergo a PET/CT scan;

研究组 & 干预措施

68Ga-FAPI-JNU

Experimental

68Ga-FAPI-JNU is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 hour after injection

干预措施: 68Ga-FAPI-JNU (Drug)

结局指标

主要结局

Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues

时间窗: 4 hour

CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)

次要结局

未报告次要终点

研究者

发起方
Affiliated Hospital of Jiangnan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunjing Yu

Director

Affiliated Hospital of Jiangnan University

研究点 (1)

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