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临床试验/NCT05444686
NCT05444686Unknown不适用

Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors

Xijing Hospital0 个研究点目标入组 45 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
主要终点
SUV of primary and metastases lesions

研究概览

简要总结

The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.

详细描述

5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.

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

入选标准

  • patients with gastrointestinal tumors: diagnosed by pathological needle biopsy

排除标准

  • refuse or cannot endure surgery pregnant women

结局指标

主要结局

SUV of primary and metastases lesions

时间窗: 2 hours after injection

The standardized uptake values (SUV) in deferent organs and lesions

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

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