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临床试验/NCT06774209
NCT06774209招募中不适用

Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
tumor size and SUVmax

研究概览

简要总结

This study is a prospective exploratory study to explore the application value of gallium 68 labeled-fibroblast activation protein inhibitor-04 Positron Emission Tomography(68Ga-FAPI-04 PET)imaging in patients with endometrial cancer and compare it with the imaging agent with better imaging effects to study its advantages. After patient enrollment, 68Ga-FAPI-04 Positron Emission Tomography/Computed Tomography(PET/CT) and Positron Emission Tomography/Magnetic Resonance Imaging(PET/MRI) examinations are performed, with the imaging agent administered intravenously at a dose of 0.02 to 0.04 mCi/Kg×patient weight (Kg), and a whole-body scan is performed 30-60 minutes later, with images processed as usual. Within 1 week before and after the examination, Fluorine18 labeled-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography(18F-FDG PET/CT) is completed, along with medical history collection and necessary laboratory tests. Subsequently, patients undergo surgical resection of the lesion and suspicious metastatic lymph nodes shown by FAPI PET/CT to obtain the corresponding pathological results. Finally, the diagnostic value of all patients in 68Ga-FAPI-04 PET/CT and PET/MR is analyzed and compared with 18F-FDG PET/CT to study the differences in diagnostic efficacy between the two.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •18-70 years old
  • •Obtaining written informed consent
  • •Being able to accept follow-up
  • •Feasible surgery or biopsy to obtain the final result

排除标准

  • •Pregnant and lactating female patients
  • •Patients who are difficult to receive further diagnosis and treatment due to their severe condition
  • •Any patients with contraindications to magnetic resonance imaging

研究组 & 干预措施

imaging examinations

Experimental

The study recruited patients suffering from endometrial cancer, and three types of examinations will be performed on them.

干预措施: three kinds of examinations (Diagnostic Test)

结局指标

主要结局

tumor size and SUVmax

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

tumor size:unit( Centimeter) Primary Tumor FAPI Uptake (SUVmax): This measures how much FAPI the primary endometrial cancer tumor takes up, using FAPI PET scans. It tells us how active the tumor cells are by comparing how much radiation the tumor tissue takes up compared to the normal tissue around it.

次要结局

  • Lymph Node Metastasis FAPI Uptake (SUVmax) and Distant Metastasis FAPI Uptake (SUVmax)(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)

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