This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.
Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy). secondary end points: * The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared. ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen). * Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.
Study Type
OBSERVATIONAL
Enrollment
120
18F-FAPI-04 PET/CT
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Diagnostic efficacy
Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site
Time frame: through study completion, an average of 1.5 year
Standard uptake value （SUV）of tumor
This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).
Time frame: through study completion, 3-4 years
Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor
This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3\*SUV）
Time frame: through study completion, 3-4 years
Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients
Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients
Time frame: through study completion, 3-4 years
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