跳至主要内容
临床试验/NCT05543954
NCT05543954招募中早期 1 期

A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月3日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Diagnostic performance1

研究概览

简要总结

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.

详细描述

Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. Moreover, 18F-FDG cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma. Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-FAPI PET/CT imaging.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with confirmed or suspected lung cancer;
  • 68Ga-FAPI-RGD and 18F-FDG(or 68Ga-FAPI or 68Ga-RGD) PET/CT within 2 week;
  • signed written consent.

排除标准

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

研究组 & 干预措施

68Ga-FAPI-RGD and 18F-FDG PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.

干预措施: 68Ga-FAPI-RGD (Drug)

68Ga-FAPI-RGD and 18F-FDG PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.

干预措施: 18F-FDG (Drug)

68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.

干预措施: 68Ga-FAPI-RGD (Drug)

68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.

干预措施: 68Ga-FAPI (Drug)

68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.

干预措施: 68Ga-FAPI-RGD (Drug)

68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan

Experimental

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.

干预措施: 68Ga-RGD (Drug)

结局指标

主要结局

Diagnostic performance1

时间窗: through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT

Diagnostic performance2

时间窗: through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT

Diagnostic performance3

时间窗: through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT

次要结局

  • The dosimetry of 68Ga-FAPI-RGD(through study completion, an average of 1 year)
  • 68Ga-FAPI-RGD uptake at different time points(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer... | 临床试验