68Ga-FAPI PET/CT in Malignant Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-FAPI: 68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).

PET/CT: 68Ga-FAPI PET/CT scan were performed 20\~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.

Study summary

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Eligibility

Primary outcome measure(s)

• The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors — three years
  Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.

Trial sites (1)

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