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临床试验/NCT05856409
NCT05856409招募中不适用

Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Tumor-to-background ratio (TBR)

研究概览

简要总结

This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.

详细描述

Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • adult patients (age>18 and<80 years)
  • patients with clinically suspected recurrent ovarian cancer
  • patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
  • patients who did not receive any other treatment 4 weeks before PET imaging

排除标准

  • pregnant patients
  • patients with poor performance status
  • patients unwilling to provide written informed consent

结局指标

主要结局

Tumor-to-background ratio (TBR)

时间窗: 1 year

TBR was calculated according to the formula:TBR=SUVmax of lesion/SUVmax of background

Diagnostic Performance

时间窗: 1 year

Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT

Maximum standardized uptake value(SUVmax)

时间窗: 1 year

Measurement of the maximum standardized uptake value of the lesion

次要结局

  • Correlation between FAPI expression and SUV in PET(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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