跳至主要内容
临床试验/NCT04441606
NCT04441606Unknown不适用

The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Patients who preformed 68Ga-FAPI-04 PSMA.

研究概览

简要总结

The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.

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

入选标准

  • The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:
  • Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
  • Better delineation of tumor extent prior to therapy
  • Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
  • Patients unable to optimally comply with the required preparation for FDG imaging.
  • The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.

排除标准

  • Age < 18 years.
  • Pregnant females.
  • Patients who are reluctant to undergo both FDG and FAPI PET scans.

结局指标

主要结局

Patients who preformed 68Ga-FAPI-04 PSMA.

时间窗: 1 year

To evaluate the avidity of various cancers to 68Ga-FAPI-04.

Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.

时间窗: 1 year

To compare the detectability of FAPI-04 and FDG for malignant lesions.

Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.

时间窗: 1 year

To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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